Incident and Complaint Reporting Documentation Quality - Tips for Channel Partners v3.pdf

Incident / Complaint Reporting to GEHC
Documentation Quality Tips for Channel Partners DOC2288467 v3
GE HEALTHCARE
Incident /Complaint Reporting to GEHC
Documentation Quality Tips for Channel Partners
January 2022
Reference: DOC2288467 v3
INCIDENT /
COMPLAINT
REPORTING
WEBFORM

Being part of the Service or Sales organization of your company, you play an active part in the Medical
Device Incident / Complaint Reporting process to GEHC.
The aim of this training is to give tips to document Incident Reporting webforms.
✓ This will help GEHC understand and assess the Incident.
✓ This will reduce the volume of follow-up questions you may have to manage later.
Recommended prerequisite
✓ Understand the EU MDR Incident Reporting process
Refer to the document DOC2288371. You can ask for it at: EUMDR.support@ge.com
✓ Understand documentation quality tips in this document
✓ Deploy the Incident Reporting process and this documentation quality tips inside your organization
Target personnel who create/update/complete Service Records + personnel who create GEHC Incident Reporting webforms
✓ Drive continuous improvement
✓ Be our contact point about Incident Reporting process and documentation quality
✓ Raise related question to GEHC. In the EU MDR area raise questions to: EUMDR.support@ge.com
Your role in the Incident Reporting Process
Your role in the Incident Reporting Process
Incident Reporting to GEHC is the responsibility of the Channel Partner
Incident Reporting to GEHC is the responsibility of the Channel Partner

Incident – or Complaint
A product incident – or complaint – is any malfunction or deterioration in the
characteristics or performance of a device made available on the market including
use-error due to ergonomic features, any inadequacy in the information supplied by
the manufacturer and any undesirable side-effect.
Serious incident
Any incident that directly or indirectly led, might have led or might lead to any of the
following:
✓ Death of a patient, user or other person,
✓ Injury: Temporary or permanent serious deterioration of the patient's, user's or
other person's state of health,
✓ Serious public health threat
Definitions

The importance of ‘telling the story’
Well documented Incident Reporting webforms …
• are the main input to complaints.
• drive timely decisions resulting in continued patient safety
and timely reporting to competent authorities.
• provide well documented complaints resulting in complete complaint
records and better investigations.
Resulting in less follow-up and rework
for both Channel Partners and GEHC

✓ Avoid webforms that involve several issues – It is not always clear if there are separate issues or not. Only
one incident per report.
✓ If you absolutely must record two separate/independent issues in the same report, provide the followings:
✓ An enumerated list describing each unique issue
✓ For each unique issue, provide the associated actions taken and repair/test/inspect data
✓ Example: 1. Issue A. Effect to functionality. Issue resolved by XXX. 2. Issue B. Effect to functionality. Issue resolved by YYY
✓ Ensure Safety flag and Device-in-use flag are filled in and consistent with the description of the incident
✓ Stick to the facts
✓ List the details of the event only
✓ Do not make unfounded assumptions or opinions
✓ Do not speculate regarding the root cause
✓ Avoid sarcasm and humor that might be taken out of context
✓ Remember: Incident Reports are auditable
Importance of ‘telling the story’ - General tips

Not submitting an Incident Reporting webform
to GEHC can contribute to late Reportable
Events to Competent Authorities.
GEHC Regulatory Affairs must submit reporting
according to strict country-specific timelines
after becoming aware an event may have
occurred.
The information provided by the Channel
Partner in the GEHC Incident Reporting
webform is critical to the report.
Depending on the event and country,
GEHC shall report to competent authorities within 1
day to a maximum of 30 calendar days from the time
GEHC is informed about the incident by the Channel
Partner.
The EU MDR requires reporting of Serious Incidents
within 15 days after GEHC has became aware of it.
Importance of reporting incidents in a timely
manner
When to report incident to GEHC?
✓ If you are aware of an actual or potential
serious incident, submit a webform as
soon as you are aware of it.
Do not wait your service activity to be
complete.
✓ Otherwise submit a webform as soon as
your service activity is complete.

Tell the story with words and phrases than can be easily understood by GEHC
and auditors
Use the “S(E)TAPLE” rules
Ease the
translation to
English
Avoid
acronym,
abbreviation
and
“telegraphic
style”
Put verbs at
correct
tense,
Put correct
punctuation
Take it
seriously
Avoid
sarcasm,
insults,
humor
Be
professional,
watch the
tone
Avoid
inflammatory
language
Don’t use
words such
as: “defect”,
“flawed”,
“violation”,
“reckless”, &
“liability”
Avoid
personal
opinions
Privileged
communicatio
ns
Respect
confidential
information.
Litigation can
make these
public
Recognize
Protected
Health
Information
Loops - Close
Complete
missing
information
Document
the
resolution
Email and
early advice
Professional
& Clear,
Lawful &
Ethical
Avoid email
chains,
“rage” &
debate
Stick to the
facts
Avoid
unfounded
assumption
&
speculation
Be clear to
limit
potential
misinterpret
ation

Incident Reporting webform: Document the story!
Safety flags
Problem description
Was the issue fixed?
How?
In use on Patient
Links to tips
Modality
tips
Impact on people
Importance of
telling the story
Importance of
telling the story
To Modality
tips
To Modality
tips
Navigation buttons

Safety Questions
Regulators closely review the Device in Use field.
Answering this question needs to be accurate. If the device was not in use, be sure to state this in
the “Patient Impact” field. Ex: “Problem identified during non-patient scanning.” or “Problem during
IQ checks”.
Be sure to answer the questions below by stating the facts. Omit all opinions or medical
judgements.
1. Death or Injury Occurred? Are you aware or were you told by a Healthcare Professional that the GE
Healthcare device caused or contributed to a serious injury or death? If there was a Death or Injury, what
was the incident date?
2. Potential of Death or Injury? Are you aware or were you told by a Healthcare Professional that the GE
Healthcare device could cause or contribute to a serious injury or death if the event were to reoccur?
When in doubt, flag it to ‘YES’
3. Device in Use during Incident issue?
Was the Device being used on a Patient when the event/issue occurred?
If you answer ‘YES’ at one of the two first questions
→ Submit our Incident Reporting webform to GEHC immediately
In any other cases submit it once your service activity is completed
Back to
Webform
Back to
Webform
Importance of
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Importance of
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To Modality
tips
To Modality
tips

Safety Flag for Actual or Potential Death or Injury
Answer Actual in case of any reports of actual Patient,
Clinician, User, or Service Engineer including (but not
limited to) the following:
✓ Death
✓ Broken/fractured bones
✓ Cuts/lacerations
✓ Warming or burns or skin redness
✓ Hair loss
✓ Hearing loss
✓ Nerve damage or loss of circulation
✓ Hypotension (Low Blood Pressure) requiring treatment
✓ Any Medical treatment
✓ Misdiagnosis
Answer Potential in case of any reports of conditions that could lead to
Patient, Clinician, User, or Service Engineer injury due to (but not limited
to) the following:
✓ Patient falls due to non-secure table locks, unsteady Patient barriers/rests ...
✓ Clinical staff or other person falls due to cables on floor, etc.
✓ Hand, Foot, Finger or Toe Pinches
✓ Fire/Smoke, melted cases
✓ Patient warming sensation / redness
✓ Electric Shock
✓ Un-commanded motion/unintended motionof gantry, table, etc.
✓ Falling or Loose Component (e.g. collimator, tube, detector, footstep, wall stand,
mount)
✓ Leakage
✓ Allegation that un-commanded / unintended radiation has occurred (double
exposure, exposure at prep, X-ray after releasing hand-switch/foot-switch)
✓ Patient data mismatch (patient A presented with data from patient B)
✓ Errors in anatomy/physiology measurements
✓ A patient was or could have been misdiagnosed
✓ Caster/wheel breakage
✓ Any electrical or metal conductors exposed? If yes, which wire was exposed and
its voltage?
Importance of
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Importance of
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To Modality
tips
To Modality
tips
Back to
Webform
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Webform

Set the Safety Flag for the following incidents (1/2)
Modality Product Event Description
Diagnostic
Cardiology
T2100 Treadmill Uncontrolled walking belt motion.
Life Support
Solutions
ADU only System Leaks in Excess of 9.0 LPM.
All critical care ventilators
Disconnected AC power cable and a disconnected display cable due to a missing fastener.
The device is running on battery while also indicating the AC mains is available simultaneously. Identified by both “On
Battery” alarms and an illuminated AC LED.
Carestation 600 Series SIB cable improperly connected
Aisys Inadequate sealing of the zeroing valve leading to deep anesthesia.
Anesthesia machines excluding ADU product
O2 Cell Leaks in Excess of 15 LPM
System Leaks in Excess of 4.5 LPM not caused by Human Error.
Patient Gas System Leaks in Excess of 4.5 LPM not caused by Human Error.
Drive Gas System Leaks in Excess of 14 LPM not caused by Human Error.
Aestiva, Aespire, Avance, Avance CS2, Aisys Flow sensor (1503-3858-000) diaphragm stuck to the top of the flow sensor housing.
All anesthesia machines and critical care
ventilators
Critical alarms did not work.
Prolonged insufficient O2 or fresh gas flow including but not limited to failures of the mixer or flow control valves.
Loss of any mode of ventilation.
Unexpected performance - AC power fail, PCB fail, and/or vent shutdowns. Battery applicability based on published
minimum operating requirements.
Caster breakage, resulting in the unit falling or Caster Detachment
All anesthesia machines and vaporizers
A failure such that it allows the user to turn on two vaporizers simultaneously.
Any malfunction of the device that resulted in light anesthesia.
All anesthesia machines
A failure such that volume delivered exceeds the set tidal volume by more than 20%.
Loss of suction.
Low flow Anesthesia with a leak of 750mlpm.
Confirmed High agent output.
Internal tube (tube that connects between the flowmeter and the output barb to the Auxiliary oxygen port) became
disconnected.
High CO2 Delivery or CO2 build up / insufficient CO2 removal.
Excess or Prolonged Airway Pressure.
Maternal and
Infant Care
Panda Bedded Warmer/Panda iRes Warmer
Product Code HDJ or PBW and Giraffe Bedded
Warmer Product code HDJ or GBW
Bedside panels, latch areas that are cracked, broken or damaged .
Giraffe OmniBed / Giraffe Omnibed
Carestation
Canopy seals contaminated with mold or bacterial growth .
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tips
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Webform
POTENTIAL SAFETY? = YES!

Set the Safety Flag for the following incidents (2/2)
Modality Product Event Description
Nuclear
Medicine
Discovery 600 series, Infinia, VG, Helix
Loose screws on the radial/lateral linear rail leading to a gap between the rotor
casting and the rail.
Discovery 600 series, Infinia, VG, Helix
Loose screws on the radial/lateral cart linear bearing may impact the radial/lateral
drive by creating a gap between the rail and the bearing.
Infinia
Detector falling down incident that stems from mechanical failure of Lateral Cart
Lead screw.
X-Ray
Proteus XR/a, Revolution XR/d and Revolution XR/d - 2X
Service incorrectly installing the collimator by not fully depressing the collimator
rotation lever when mounting/installing the collimator to the mounting flange.
Proteus, Proteus US, Precision 500D, Precision 500D –
Aurora
URP detector tray base plate contains sharp edges/burrs that were not removed
during the manufacturing process.
CT Revolution CT Pinch protector off leaving standing flat-head screws.
Monitoring
Solutions
Carescape Respiratory Modules
Inaccurate EtO2 and/or FiO2 values caused by missing solder in the coil wires of the
miniOM sensor.
Telemetry Monitoring Systems (ApexPro, PatientNet)
Failure of the medical device to detect and recognize a life threatening abnormal
heart rhythm alarm due to a malfunction.
Central stations (CIC, iCentral), telemetry systems
(ApexPro, PatientNet, etc.), patient monitors (all)
Any spontaneous de-escalation for an alarm priority or life threatening abnormal
heart rhythm setting to any lower priority due to a malfunction.
Physiological Patient Monitor
Mount, monitor or other item falls off of the wall with energy ≥ 100 Joules, due to a
malfunction.
Products with an external power supply, that could
normally be used in a near patient environment
Power supply cover comes off or apart exposing internal electrical components.
PDM-Masimo v2.8 or earlier
Frozen SPO2 value that is inaccurate and no longer changes to reflect patient’s
clinical condition with confirmed system run time >2 years
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Webform
POTENTIAL SAFETY? = YES!

Modality examples when the device “In use” flag shall be set to YES
AW: images/patient data being reviewed by the customer
LCS: patient is connected to monitor, patient is in warmer, surgery in progress
Surgery: system being used during a case, surgery in progress
CT/PET: patient was injected – may or may not be actively scanning, patient scanning in process, images/scans
being reviewed
Mammo, Vascular, X-Ray: Patient in room, images/scans being reviewed, patient exam in progress
MR: patient exam in progress, images/scans being reviewed
Ultrasound: patient exam/procedure in progress, scans or imaging are being acquired or reviewed
Device in use on patient when the incident
occurred
Importance of
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Problem Description
A great problem description sets the foundation for future reporting decision making by GEHC.
It shall be described in such a way anyone without a technical background can understand what
happened. It needs to stand on its own. Describe what was found in detail.
Ensure the description of the problem is not just the problem description as defined by the
customer but validated with the value-added of your Service Engineer.
For example, the customer reported: Locks don’t lock. A good problem description should be:
Customer description is misleading. I confirm that table wheel locks did lock but would not
unlock.
What constitutes a good description of the problem?
❑ What was the customer doing or trying to do?
❑ What was the cause of the issue ?
❑ What was the impact on the system functionality?
Don’t just write “monitor is black”, say which monitor and so what? = impact on functionalities and
patient
❑ Describe how failure effects the use/function of the device?
❑ Was the customer’s stated issue able to be confirmed?
If not reproduceable, state this in the service record.
Importance of
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Problem Description
Certain phrases do not provide adequate details and should not be used.
AVOID USE THIS
Broken handle → Table handle had small cracks. Cosmetic issue.
No impact on functionality. No missing pieces.
Damaged part → Paddle had a large dent and scratches on the top.
Table not functioning → Table top locks would not engage/lock.
System not working → System would not boot up.
Intermittently exposes → System would not take an exposure occasionally.
Part number only → Part description, #123 and part problem detail.
Importance of
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Importance of
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Back to
Webform
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Webform

What happened to individuals involved by the issue?
Patient impact can be the patient, the technologist, service staff, and anyone in the room when the
issue occurred.
Impact is not limited to injuries. State the facts and do not add any medical opinion.
Even when there is no injury, an individual’s experience is important to understand, for example,
the exam rescheduled, delayed, etc.
❑ What type of procedure was being performed on patient/affected individuals?
What was the user doing with the device when the issue occurred?
❑ Was there any individual potentially or actually injured?
(Clinician, Biomed, Service, etc., and including yourself)
❑ How does this issue affect the use of the equipment?
What interventions were required on the part of the clinician?
❑ What was the consequence to the affected individual and the outcome of the exam?
Includes delay or reschedule of exam to initial patient. If a person was involved, there was
impact.
❑ If In-House activity, request and document Patient Impact.
Document information or document the attempt was made.
❑ Patient impact unknown? Document and include individual’s name and role you spoke with.
What constitutes good Patient Impact documentation?
Importance of
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What was done to fix the issue
Be detailed when documenting actions taken to resolve the customer issue, including
listing the parts used. If the customer performed the service, document any
recommendations you provided to the customer.
Stick to the facts, what was done → Use past tense.
❑ What Troubleshooting / diagnosis action was done?
❑ What was the conclusion as to the cause?
❑ What was the fix completed to resolve the issue?
❑ What parts, if any, were used to fix the issue?
❑ If the Problem was not corrected, what was the reason for not correcting?
❑ Was there a workaround provided? If yes, state the work around given to the
customer.
❑ If the customer performed the service, document this in the Incident Reporting
webform
❑ Include any recommendations provided to the customer for repair.
What constitutes good Actions Taken/Repair documentation?
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Certain phrases do not provide adequate details and should not be used.
Some examples to avoid and the alternatives:
Avoid: Instead use:
Replacing part Part replaced because xxxx
“I spoke to the customer“ Tell what you said to customer, actions to take, customer feedback
(applies to Inhouse support)
A Service Engineer will go onsite Tell what are your findings, recommendations, actions taken to prepare the
onsite visit. State this is a ‘remote support’.
Cannot reproduce / intermittent Write: I kept the system under monitoring for 2 weeks. still not reproducible,
I close the job, another job will be created if the problem reoccurs.”
Importance of
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Repair Test and Inspection Data are critical in proving the device was tested according
to validated procedures and that the equipment is safe and effective for use on
patients
What constitutes good Repair Test/ Inspection documentation?
❑ Problem was corrected, or not corrected.
❑ If no resolution, explain why. What is the plan to complete service?
❑ List test and inspection data that confirmed system is meeting specifications,
for example: [system] passed in specification per Service Manual XXXX.
❑ State the appropriate conclusion – what is the status of the system? (i.e.
System passed; system is functional)
If a test is not completed, the appropriate justification should be documented
within the Incident Reporting webform.
Importance of
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Other documentation guidelines
Situation Instructions Proper Documentation
In-house FE
Ownership. Not a
Chanel Partner
employee,
contractor or
distributer.
The RSL, FE or Technical Support must inquire about
patient impact and document the attempt. The
Service Record must state the service was
performed by an in-house FE.
If no complaint, document as consulting provided
and what service was recommended : Write what
you said to customer.
Customer In-house FE stated problem occurred
during Quality Assurance (QA) scans in the morning
and no patient was in the room.
Recommended replacement of the collimator and to
perform light field to X-ray test per the service
manual. Service to be performed by customer In-
house FE.
Issue found during a
PM
PM is not a complaint but the issue found during the PM
is a complaint
Write it down clearly : “Problem found during a PM: xxxx.”
You cannot get
information from
Customer about
patient impact
Document the fact that you reasonably tried to get the
information from the Customer.
We contacted the customer, No more information is
available about patient impact.
We made attempts to get patient impact from Customer.
No more information is available.
Part order If the customer calls you to order a part WITHOUT an
allegation of issue (like a part or accessory for stock), this
is NOT a Complaint.
If the Customer calls you to order a part saying it is for a
replacement, this is a Complaint. Ask the customer “what
is the problem, why the part needs to be replaced?
Please make the problem description / action taken clear
and consistent.
Customer ordered part XX for stock. No allegation of
problem reported by customer.
Customer ordered part XX as a replacement in order to
solve the issue YYYYY + impact on functionalities +
patient impact.
Importance of
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Situation Instructions Proper Documentation
OEM is defective? Give manufacturer name, model and S/N. The CHU will
inform the OEM.
If you don’t have those information please document it,
else the GEHC will ask.
OEM manufacturer is XXX.
We don’t have information about manufacturer name
and product identifier.”
PACS issue GEHC needs to know if it is a GE PACS or not.
If it is a GE PACS, the tam will treat the incident.
If this is not a GE PACS, you should not report the
incident to GEHC but to the manufacturer of the PACS.
The problem is on the PACS side.
Always state if Data send to PACS are correct or
corrupted (patient name mix, etc.)
PACS is a GE PACS xxx.
Other documentation guidelines
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Problem Description and Impacts. Modality tips
We recommend that Channel Partners Service Engineers know those most frequently asked questions.
By adding those information in your Incident Reporting webform, you’ll give the information GEHC needs to
complete the assessment of the incident; you’ll avoid GEHC’s requests for additional information.
Click on the links !
Vascular Mammo Surgery LCS MS
(Monitoring)
LCS LSS
(Life support)
CT MR Nuclear
Medicine
UDI
Where is the label?
LCS DCAR
(Cardio diag)
Ultrasounds LCS ICAR
(cardio interventional)
LCS MIC
(Infant care)
About UDI …
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RRF Lunar
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MAMMO TIPS (1/3)
Most probable potentially reportable events
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Modality tips
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Modality tips
Importance of
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MAMMO TIPS (2/3)
✓ Patient involved?
o If Yes, what was the patient experience?
Exam rescheduled or delayed / patient re-imaged / injuries / two injections, etc.
o If no information has been provided by the customer, use the tip: “Customer contacted: No further information available.”
o If you state “No patient involved” it means that problem did not occur during patient exam ( no rescan ).
It is different than “No patient impact” ( possible rescan )
✓ Image artifact?
o If Yes, when was the artifact detected? Was it on IQ Test Image or was it on Patient Image?
o If artifact detected on patient image, has the patient been re-imaged?
✓ Compression issue?
o If Yes, what was the highest compression force value in Manual (>30 DN?) / Motorized (>20 DN?) mode?
o Was the applied compression force equal to the displayed compression force? If not, what was the gap?
o If motorized compression unavailable, is the manual decompression still available to release the patient?
o If compression value is unknown, write it down in your debrief
✓ Collimator misalignment? If Yes, address the following 3 questions:
o Was the gap between the x-ray beam and the light field greater than 1.32cm?
o Was the gap between the xray beam and the detector borders greater than 0.5cm?
o From which side was the misalignment? (chest wall, left, right or back)?
o If misalignment value is unknown, write it down in your debrief
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Modality tips
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Modality tips
Importance of
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MAMMO TIPS (3/3)
✓ Paddle misaligned or not straight and parallel to the chest wall edge of the image receptor?
o If yes, was the paddle visible on the patient image? If yes, was the patient re-imaged?
✓ Paddle damaged?
o If Yes, was the paddle used on patient after being damaged?
If Yes, were there any consequences for the patient?
✓ Patient/exam data error? Risk of mismatched patients
o Was a patient exam sent to PACS with a wrong information? (patient name, laterality, view name, etc.)
o What was the root cause? Is it an operator error?
o If wrong information sent on PACS, is the problem corrected on PACS or has a patient been re-imaged?
If no information, write “Customer informed about the correction to perform on PACS. No more information available.”
✓ Issue related to another device System ID or OEM Product?
o What is the Manufacturer and the SID of referred other product? The OEM Manufacturer will be informed by CHU
✓ Data transfer issue?
o Ensure the defective device is clearly identified: Mammograph, IDI station, GE PACS, Non-GE PACS …
o If it is a GE PACS, the complaint will be transferred to the CHU in charge of PACS. SID will be requested.
o If it is not a GE PACS, write “NON GE PACS”, the complaint will be closed as NAC (not a valid complaint).
o If you don’t know, use the tip: “we don’t have information about the PACS’s model and manufacturer.”
o Write “ No patient data lost ”
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Modality tips
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CT TIPS
✓ Was there a patient involved? What was the patient Impact? (Re-imaged/injections/injuries) Provide details.
✓ Was there a malfunction Uncommanded X-Ray/failure to shutdown X-Ray generation while exam is active and patient is
stationary?
✓ Did the scan abort occur during a patient scan? If Yes, did it lead to rescan of scout or series?
✓ Did image artifact occur during a patient scan? If Yes, did it lead to rescan of scout or series?
Please describe the artifact.
✓ Was the patient identifier (patient name, medical record, accession number) edited?
If yes, was it corrected before the images are read by radiologist? Describe the identifier that was edited.
✓ If the issue is related to leaking phantom, did the phantom break because it was dropped by the operator? Was it leaking in a
walkway used by patient or staff?
✓ Was the scan performed at different slice location or start/ end time other than prescribed in the scan?
If Yes, describe and Select Safety Concern flag to “potential”
✓ Injector Complaints
✓ Is the injector system and cable resale by GE Healthcare?
✓ Provide injector system (Product name, Manufacture, Model number, Serial number)
✓ Did you or the customer inform to Manufacturer about this issue?
✓ Date and time mismatch
✓ How long did date/time drift?
✓ Was any patient scanned with wrong date/time? If patient was scanned with wrong date/time?
✓ Was the exam corrected prior to being networked off the scanner? - Was there any impact to the patient (e.g.
misdiagnosis or treatment errors)
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Modality tips
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Modality tips
Importance of
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MR TIPS
✓ Was there a patient involved? What was the patient Impact? (Reschedule/Re-imaged/injections/injuries)
Provide details.
✓ Did a ferrous/warming/hearing loss event occur?
If yes flag Safety as "Actual".
✓ Source of fluid on floor? Was fluid on the scan room floor greater than 2.5cm?
✓ Did more than one table castor fail to lock?
✓ Did the issue involve a coil?
If yes please provide the Serial and Model number of the coil
✓ Was the failure on MRU?
If yes what was not functioning: heaters, F1 fuse, not connected or battery charging function?
✓ Date and time issue? Confirm if this was a date and time issue or just a time issue? How much was the date and time discrepancy
with the correct time?
✓ Was there any cable or conductive material in contact with the patient at area of injury?
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ULTRASOUNDS TIPS
✓ Was there a patient involved? What was the patient Impact? (Reschedule/Re-imaged/injections/injuries). Provide details.
✓ Describe how the issue affects the use of the system?
✓ Did the issue occur during an exam?
If Yes, please verify if the exam performed is critical exam? What types of Exams were being performed?
✓ How did the issue affect the patients and the outcome of the exams? Were the exams completed with acceptable results, or will
an exam need to be repeated?
✓ Did the issue involved a Probe?
If Yes, please provide the Serial and Model number.
✓ Did the Probe have visible damage?
If Yes, Describe the damage?
✓ Was there damage to probe involving Cable Jacket/Strain Relief cuts or holes?
If Yes, specifically describe what is being exposed.
✓ Was there damage on TEE/TOE Probe?
If yes, when was this damage discovered? Describe any testing that uncovered the damage, as Bit Hole Indicator, Electrical Safety
testing. Include the Model Name and Serial Number.
✓ Was there a defective Advanced Power Supply II causing a rapid increase in probe temperature? Select Potential for this
malfunction.
✓ Issue related to Patient data?
If yes, please provide details data backup done by the customer or data has been lost completely
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NUCLEAR MEDICINE TIPS
✓ Was there a patient involved? What was the patient Impact? (Reschedule/Re-imaged/injections/injuries) Provide details.
✓ Did the problem happen during QC or during clinical use?
✓ Update if collimator could not be removed from detector, or it was stuck halfway on detector and halfway on collimator cart?
✓ If the problem is related to the Workstation:
✓ Was the problem with the PC HW/HD/Database/OS/App?
✓ Was there any clinical data loss?
✓ What is SW version?
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RRF TIPS
Radiology systems
✓ Was there a patient involved? What was the patient Impact? (Reschedule/Re-imaged/injections/injuries). Provide details.
✓ Issue related to Broken or Damaged equipment?
If Yes, was the part functionally or cosmetically broken? Describe damage.
✓ Would the system not turn on? Did the unit stop working in the middle of an exam?
✓ Did the Table Floats or Slips (RFF ONLY)?
If yes, did the system lose power? Were the brakes not working properly (holding or not releasing)?Page 9 / 9
✓ Were there any electrical or metal conductors exposed?
If yes, which wire was exposed and its voltage?
✓ Was there an oil fluid leak?
If yes, was any oil/fluid on the floor and approximate size?
✓ Was the issue related to detector?
If, Yes, Is detector NON_GE? If yes, please record the OEM name.
✓ Was Fluoroscopy control sticking and resulted in emission of fluoroscopy upon release of control?
✓ Did user only commanded one radiographic exposure but received multiple?
✓ Did Radiographic exposure emitted when fluoroscopy was commanded?
✓ Did the user only commanded PREP exposure but the system produced PREP and EXPOSE?
✓ Please capture it is Fixed or Mobile RAD unit
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LCS / DCAR TIPS
Cardio diagnostics
✓ Was there a patient involved? What was the patient Impact? (Did a patient experience mistreatment or delayed treatment
related to this event or was alternative equipment available to finish the test).
Provide details
✓ Is the issue on a different or multiples devices? If yes provide serial number and description of the device that caused the issue.
✓ Was there an issue with the treadmill? Flag any uncontrolled belt motion as a Potential Safety Concern.
If yes:
✓ Did the treadmill stop unexpectedly?
✓ When the unexpected stop occurred, was it similar to E-stop (near immediate halt to belt motion),
or slow down and stop over time (similar to standard stop command)?
✓ Approximately what speed was the belt moving at When the belt began to slow down and how long did it take for the belt
to stop moving?
✓ Did the treadmill travel backwards during patient use?
✓ What was the distance the belt traveled backwards (was it a slight shift or a greater distance)?
✓ How fast did the belt move in the backward direction?
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LCS / ICAR TIPS
Cardio monitoring integrated solutions
✓ What system is this? (cardiolab, combolab, maclab)
✓ Procedure Type
✓ Alleged Patient Consequence
✓ Intervention Required
✓ Was defib, portable monitor or IABP available/attached during event?
✓ Could vital signs be assessed during troubleshooting? How?
✓ Did the patient need to be moved to another room or site?
✓ Did any part of the procedure need to be repeated?
✓ What software version is being used?
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LCS / MIC TIPS
Maternal and Infant cares
✓ Was there a patient involved? What was the patient Impact? (Changed beds/injuries)
Provide details
✓ Was the Pre-use checkout procedure performed before admitting the patient?
If yes, were failures reported or observed?
✓ What mode is bed in (servo, baby or air)?
✓ What alarms were active and what messages were displayed?
✓ What type of patient probe or transducer was used?
✓ Are strip chart/readings available?
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VASCULAR TIPS (1/2)
Xray Interventional Systems like Innova
Most probable potentially reportable events
-Can Customer continue the exam to the end??
The CHU needs those information to complete the evaluation of the risk
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VASCULAR TIPS (2/2)
Xray Interventional Systems like Innova
✓ Patient involved? What happened to patient? Reschedule/Re-imaged/injections/injuries/transferred to another room. Specify.
o Try to know what happened to Patient once in the other room
o If applicable, use the tip: “Customer contacted: No further information available about patient impact.”
✓ Did Customer confirm Patient image can / cannot be used for medical diagnosis?
✓ Issue not recovered or Issue recovered by Customer? Was the customer still able to start/continue an exam despite this
issue?
✓ Monitor not working? Specify the issue and impact on functionality. Specify which monitor: Live / Reference / DL / LDM / AW
monitor / MacLab. Specify its location: in control / exam room?
✓ Noisy tube? Specify if more than 65dB or not.
✓ Unwanted motion of gantry? Specify which axis.
✓ Motion loss, x-ray loss, or impact on image quality?
o Specify: Only fluoro, rad?, both?. Which motion?, etc.) and can the customer still use the image? can the exam continue?
✓ Free floating of table top? Specify which movement.
✓ Image chain misalignment? Specify: Xray tube / collimator / detector.
✓ Only Fluoro / Record(cine) not working? Specify.
✓ X-ray (Fluoro AND Record(cine)) not working? Specify.
✓ ARO? Unwanted Xray emission?
✓ Stuck Fluoro/Record(cine) footswitch? Unwanted Xray emission (ARO)? Specify.
✓ Accidental uncommanded radiation occurred? If applicable, attach the investigation template.
✓ Write “no uncommanded xray emission” when applicable
✓ Data transfer issue? Give the cause. Say to which device the data is transferred to, if the workstation is a GE workstation or not.
o If you don’t know, say “we don’t have information about the workstation’s model and manufacturer.”
o If issue is Hospital network, write it down in your debrief.
✓ User error? Please specify: Component failed / wrong configuration, etc.
✓ Cover broken. Give the cause especially if it is on Detector. Say if it was a user error, a normal wear.
✓ PACS. Say if this was a GE PACS or not.
✓ OEM (Injector, Shiller, light…). Give the name of the Manufacturer (even before sending the quote)
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LUNAR TIPS
Densitometry, Skeletal & Metabolic Health Assessment
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✓ Was there a patient involved? What was the patient Impact? (Reschedule/Re-imaged/injections/injuries)
Provide details.
✓ Is issue related to Broken or Damaged equipment?
If Yes, describe damage. (Was the part functionally broken or cosmetically broken? Did the part completely break off?
✓ Is the issue related to unit not working?
If Yes, how was the unit not working (describe symptom)? Would unit not turn on? Did the unit stop working in the middle of
exam?
✓ Were there any electrical or metal conductors exposed?
If yes, which wire was exposed and its voltage?
✓ Was there an oil fluid leak?
If yes, was any oil/fluid on the floor and approximate size?
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SURGERY TIPS
✓ Was there a Patient involved? Reschedule/Re-imaged/injections/injuries? Provide details.
✓ Impact on system functionality for customer: Shut down, Prevent system for booting up., Loss of fluoroscopy, Hand switch, No Xray,
Unexpected Xray, Loss of motor movement, etc.
✓ Was the customer able to recover system functionality? rebooting, press-any-key, moving a cable, etc.
✓ No Boot. C-Arm or Generator or Workstation will not boot up, will not complete boot up, or has problems booting up
✓ Lock-up. System locked up, froze, or blocked.
✓ Brakes / Locks. Which locks / brakes were not functioning properly? Were locks binding, slipping, or not holding at all?
✓ Collimation Issues. What was the issue (e.g. coned down, stuck in full open, etc.)? Was the user able to produce usable images?
✓ Cover cracked/ broken/ damaged. Was there a visible gap due to the issue? (Our concern: Potential of fluid ingress vs a cosmetic issue)
✓ Damaged Cables & Plugs. Which cables or plugs were damaged or not functioning properly?
Did the damage present any risk of electrical shock (i.e. bare/exposed wires)?
✓ Error Messages Displayed. What error messages were reported or observed? Could the messages be by-passed by the user to allow
continued use of the product? Were any start-up/lock-up issues reported by the user? Was the product able to produce x-ray?
✓ Storage issues. Were any images lost as a result of the issue? Were any images mislabeled with other patient information?
✓ Image / Data loss or mix-up. Were any images lost as a result of the issue? Were any images mislabeled with other patient info?
✓ Low mA or low KV error messages . Did the presence of the error(s) affect Image Quality?
✓ Image Quality. Provide description of issue. Impacted the ability to view / interpret the images on screen? (Issues such as lines, flicker, burn in)
✓ Monitor Issues. Was the issue with (Left, Right, Reference, or auxiliary) monitor?
Right workstation monitor not working for SLC products 98/9900 and Elite – Is the system a Vascular, Cardiac or PMCare configuration?
✓ X-ray Controls. Was the problem with the footswitch, hand-switch, dog-house or other controls?
Did the problem cause loss of x-ray production? Or, unintended x-ray production (i.e. without command)?
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LCS / LSS TIPS
✓ Know the safety reportable malfunctions list (page 11)
✓ What happened? What resulted from that failure? Impact on functionalities?
✓ Was the flow sensor part #1503-3858-000 stuck in open position?
o If you cannot get the information, write: “Flow sensor position is unknown. No further information is available.”
✓ Was the leak rate above 4.5 LPM?
o If you cannot get the information, write this: “Leak rate is unknown. No further information is available.”
✓ From flow or pressure sensor issue, was any mode of ventilation lost?
o Did bag/vent switch fail to switch from mechanical to manual ventilation?
o Was Mechanical ventilation lost?
o Was Manual ventilation lost?
✓ Did the volume delivered exceed 20% of the set tidal volume?
o If yes, provide Set, delivered and monitored values.
✓ Was there any over or under delivery of any gas/agent?
✓ Did the failure cause high pressure?
✓ Did the unit fail to switch to battery back-up when AC power was lost?
✓ Did audio alarms fail to function? Which alarm?
✓ Could multiple vaporizers turn on at the same time?
The system has six modes of Mechanical ventilation
▪ volume control (VCV)
Optional:
▪ pressure control (PCV)
▪ synchronized intermittent mandatory/pressure support
(SIMV/PSV)
▪ pressure support (PSVPro)
▪ synchronized intermittent mandatory-pressure control
(SIMV-PC)
▪ pressure control ventilation-volume guarantee (PCV-VG)
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LCS / MS TIPS
✓ Any reported patient harm or missed alarm due to this issue?
✓ Did any patient experience mistreatment or delayed treatment related to this event?
✓ How long was patient monitoring lost and for how many patients?
✓ Was alternate monitoring available?
✓ Software version at the time the issue occurred?
✓ What is the gas module type and device serial number?
✓ What is the part# of the NIBP accessories?
✓ What is the defective ECG cable part number?
✓ What is the cause of the issue?
Why part was replaced? Cause of damaged ECG accessories, defective DAS? Why SW was re-installed?
Is this is a loss of NIBP due to the NIBP Cuff? etc.
✓ Device fell. What caused the device to fall? How far did it fall? Impact?
✓ What was the error message observed?
✓ Missed arrhythmia, parameter or technical alarm? Provide event details and testing activity.
✓ Inaccurate values provided by the E-NMT module? State if the module was used with an ElectroSensor.
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LCS / MS. LCDs
✓ Liquid Crystal Displays May be used with multiple products, including Non-GE systems.
✓ While a display is sometimes referred to as a ‘monitor’, this should not be confused with the term ‘patient monitor’, which is the
medical device. A display may be a component of a patient monitor.
✓ We Need to identify the medical device involved in the event, sometimes referred to as the host device. A display itself is not
necessarily a medical device.
✓ Another way to look at this: What equipment was the display plugged into?
✓ Information desired: the make/model/serial number of the GE patient monitor
Central Station examples:
• CSCS
• CIC Central
Bedside examples:
• B850 Monitors
• Solar 8000i
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LCS / MS. Patient Monitoring Accessories
✓ Accessories include, but are not limited to, NIBP Cuffs/hoses, ECG cables/lead wires/SPO2 sensors/cables, i.e. any patient
connected accessory.
✓ Many accessories are medical devices in and of themselves.
✓ Many accessories are distributed by GE on the behalf of other manufacturers. We need to identify the medical device involved
in the event, as we have obligations to notify our OEM partners when we received complaints against their equipment.
✓ Information desired: the make/model/part number/lot code of the accessory.
Accessory Examples:
• Critikon Dura-Cuf/air hose
• DS-100A SPO2 sensor
• ECG Trunk cable
• Alaris temperature probe
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LCS / MS. Networked Equipment
✓ Network accessories include, but are not limited to, network switches/routers, Ethernet cables, fiber-optic equipment, Telemetry
antennae.
✓ We need to identify the medical device involved in the event.
✓ Network components are not medical devices, but routinely affect medical devices.
✓ Information desired: the make/model/serial number of the GE patient monitor affected by the network issue.
✓ Another way to look at this: What equipment was plugged into the network component?
Network Accessory Examples:
• Cisco switch problems
• Disconnected Ethernet cable
• Telemetry antenna or access point disconnected
Medical device affected:
• CIC/CSCS central station
• Bedside monitor
• Telemetry Server
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LCS / MS. Telemetry Equipment
✓ Telemetry equipment includes Transmitters, Telemetry Servers, Receiver Subsystems, Access Points, Antennae, etc..
✓ We need to identify the appropriate medical device involved in the event.
✓ Telemetry issues routinely affect central stations, but the central station is not the cause of the problem.
✓ Information desired: the make/model/serial number of the GE telemetry product causing the issue.
✓ Another way to look at this: What equipment was causing the dropout, signal loss, artifact at the viewing location?
Symptom seen here
(central station) But … Problem found here
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LCS / MS. Multi-Parameter Modules
✓ Multi-parameter modules can be used in multiple products such as patient monitors, anesthesia machines, and respirators.
✓ Multi-parameter modules are medical devices themselves.
✓ Information desired: the make/model/serial number of the affected module involved with the event.
Multi-parameter Module Examples:
• E-sCAiOV
• SAM
• PDM
• E-PRESTN
• PSM
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UDI for Compliance
To be compliant with regulators, UDI is required - per the UDI compliance dates - in the GEHC Incident Reporting web
form.
As part of compliance requirements, all Medical Devices, unless UDI exempt, are allocated a UDI.
Certain products tie the UDI directly to the software version and can aid in answering the question if a product is UDI applicable.
Products may or may not be GE Healthcare products, may be hardware or software items, may have more than one UDI mark, and
may be a Field Replaceable Unit.
The location of the UDI label depends on products: See appendix 1.
If you do not provide the UDI, GEHC will come back to you via follow-up emails.
+ =
(01)1122222333334 (21)0A1B3C4D5E6F7G8H
UDI
(21) 0A1B3C4D5E6F7G8H
Production Identifier
GTIN/Device Identifier
(01)1122222333334
UDI Example
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Software version is also important to UDI and
complaint information. Some versions require
UDI while some versions are not applicable for
UDI. Always check the help screen on the device
for UDI applicability.
The model number and serial number also play
an important.
Make every attempt to obtain UDI information
and document in the webform.
UDI – Additional Considerations
✓ MRI coils and Ultrasound Probes are Finished Medical Devices and
require the model number and serial number, even if the probe or
coil is not replaced. Customer replaceable units (probes) must also
be captured. If not on site, seek this information from the
customer.
✓ ICAR – it is important to have the software version included as this
indicates if the equipment will be UDI applicable.
✓ For Devices with multiple serialized GE Healthcare components
connected to the equipment having an issue, document the model
# and serial # of each device directly connected.
✓ If the Device uses software, include the Version.
✓ Accessories’ part numbers, batch or lot numbers included in
service activities must also be included in the webform.
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Appendix 1
UDI Label location per Product type
Examples
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ULTRASOUND product example:
Invenia ABUS (Class III)
UDI Label
Scan Station Work Station Stand-alone SW
NOTE: Probes are
considered medical devices
and will be labeled.
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Mammography product example:
Seno Essential with Tomo (Class III)
Recon PC Housing
UDI Label
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CT product example: Revolution Discovery HD
System UDI
Tables
(1700, 2000, 675lb )
Note:
The XRAY Tube and Generator are Class
I Medical Devices (due Sept 2018).
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MR product example: Optima MR450W
System UDI
COILS
1.5T GEM Posterior Array
1.5T GEM Head Neck Unit
1.5T GEM Anterior Array
1.5T GEM Peripheral Vascular Array
1.5T 3-ch Shoulder Array
1.5T GEM Breast Array
1.5T Open RT Array Kit
DISCOVERY MR 450- 1.5T SPLIT HEAD COIL
Tables
Gem
Non-Gem
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VASC product example: Discovery IGS 730
VASC Discovery IGS 730– (Class II – Sept 2016)
System UDI label located on C arc
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MS product example: Carescape Monitor
VASC Discovery IGS 730– (Class II – Sept 2016)
System UDI label
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AW product example: Software
Distribution UDI not Medical
Device UDI.
DO NOT SCAN THIS UDI#
IMPORTANT: The UDI# on the DVD is
different from the UDI# in the software as it
contains the manufacturing date of the
media.
The UDI# is found in the software itself and can be
accessed from the:
1. Environment configuration Screen
2. System Healthpage screen
The UDI# is found in the software itself and can be
accessed from the:
1. Environment configuration Screen
2. System Healthpage screen
1
2
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