The US FDA regulates medical devices to ensure they are safe and effective. There are three classes of medical devices with increasing regulatory controls based on risk. Class I devices have general controls, Class II devices have general and special controls, and Class III devices require premarket approval. To market a device in the US, manufacturers must classify their device, submit the appropriate premarket notification or application, and complete an establishment registration and device listing. The FDA reviews submissions to ensure devices reasonably assure safety and effectiveness.

1. US FDA
Dr. Mohammad Kausar

2. Medical Device Markets

3. About US-FDA
• Part of the U.S. Department of Health and Human
Services
• Protect public health by ensuring medical
devices’
– safety
– efficacy
Amongst others……
• Helps speed innovations that make medical
products more effective, safer, and more
affordable…..

4. What does FDA regulate?
• Foods: dietary supplements, bottled water, food additives, infant formulas
• Drugs: prescription drugs (brand-name and generic), non-prescription (OTC drugs)
• Biologicals: vaccines, blood and blood products, cellular and gene therapy
products, tissue and tissue products, allergenics
• Medical Devices:
– simple items like tongue depressors and bedpans,
– complex technologies such as heart pacemakers
– dental devices
– surgical implants and prosthetics
• Electronic Products that give off radiation, including:
– microwave ovens
– x-ray equipment
– laser products
– ultrasonic therapy equipment
– mercury vapor lamps
– Sunlamps
• Cosmetics, Veterinary Products, Tobacco Products

5. Agency

6. Safety & Effectiveness
• “So to market a medical device in the United
States, we have to follow the Federal Food, Drug,
and Cosmetic Act, or the FD&C Act.”
• Center for Devices and Radiological Health, or
CDRH, evaluates the evidence for the safety and
effectiveness of medical devices.
• Safety means that the device poses no significant
risk to users, or that the risks are mitigated,
meaning they can be adequately controlled.
• Effectiveness means the device can treat the
disease as labeled.”

7. Laws Enforced by FDA
• Food and Drugs Act of 1906
• The Federal Food, Drug, and Cosmetic Act of 1938 was passed after
a legally marketed toxic elixir killed 107 people
– The law authorized FDA to demand evidence of safety for new drugs,
issue standards for food, and conduct factory inspections.
• The Kefauver-Harris Amendments of 1962, which were inspired by
thalidomide tragedy in Europe (FDA's vigilance prevented drug's
marketing in US)
– Strengthened rules for drug safety and required manufacturers to
prove their drugs' effectiveness.
• The Medical Device Amendments of 1976 followed a U.S. Senate
finding that faulty medical devices had caused 10,000 injuries,
including 731 deaths.
– The law applied safety and effectiveness safeguards to new devices.

8. FDA's regulatory framework

9. Marketing Medical Device in US
• Medical devices marketed US are subject to
– the regulatory controls in the Federal Food, Drug, and Cosmetic Act
(FD&C Act) and
– the regulations in Title 21- Code of Federal Regulations (21 CFR) Parts
1-58, 800-1299.
– Medical devices that emit radiation are also subject to regulations for
radiation-emitting electronic products cited in 21CFR Parts 1000-1050.
• Premarket requirements
1. Classify Your Device
2. Choose the Correct Premarket Submission
3. Prepare Appropriate Information for Premarket Submission
4. Send Premarket Submission and Interact with FDA Staff during
Review
5. Complete the Establishment Registration and Device Listing

10. 1. Classify Device
• Class I – Lowest Risk
An example of a Class I device is a hand held stretcher.
Class I devices are subject to general controls.
• Class II – Moderate Risk
Examples of Class II devices are Ethylene oxide gas
steriliser and non-invasive blood pressure monitors.
Class II devices are subject to general controls and
special controls.
• Class III – Highest Risk
An example of Class III device is a heart valve. Class III
devices are subject to general controls and premarket
approval.

11. Examples

12. Examples

13. Examples

14. Examples

15. Regulatory Controls
• General Controls-
– Apply to all medical devices.
– Provisions that relate to
• adulteration;
• misbranding;
• device registration and listing;
• premarket notification;
• banned devices;
• notification, including repair, replacement, or refund;
• records and reports;
• restricted devices; and
• good manufacturing practices.

16. Special Controls
• Usually device-specific and include
– Performance standards
– Post-market surveillance
– Patient registries
– Special labeling requirements
– Premarket data requirements
– Guidelines

17. Performance standards-CT
• Information to be provided for users
– Conditions of operation
– Dose information at various locations
– Imaging performance information
• A statement of the noise
• graphical presentation of the modulation transfer function
• statement of the nominal tomographic section thickness
• graphical presentation of the sensitivity profile
• phantom or device and test protocol or procedure
– Quality assurance
– Control and indication of conditions of operation
– Tomographic plane indication and alignment
– Beam-on and shutter status indicators
– Scan increment accuracy
– CT number mean and standard deviation

18. Marketing Medical Device in US
• Medical devices marketed US are subject to
– the regulatory controls in the Federal Food, Drug, and Cosmetic Act
(FD&C Act) and
– the regulations in Title 21- Code of Federal Regulations (21 CFR) Parts
1-58, 800-1299.
– Medical devices that emit radiation are also subject to regulations for
radiation-emitting electronic products cited in 21CFR Parts 1000-1050.
• Premarket requirements
1. Classify Your Device
2. Choose the Correct Premarket Submission
3. Prepare Appropriate Information for Premarket Submission
4. Send Premarket Submission and Interact with FDA Staff during
Review
5. Complete the Establishment Registration and Device Listing

19. Controls in US FDA Medical Devices
Center for Biologics Evaluation and Research
Center for Drug Evaluation and Research
Center for Devices and Radiological Health
HDE (Humanitarian Device Exemption)-Class III devices for patients with rare diseases
Humanitarian Use Device (HUD)-FDA’s Office of Orphan Products Development(OOPD)

20. 510 (k)
Predicates
Devices legally marketed
in the U.S. before May
28, 1976 not significantly
modified, regulation
requiring a PMA
application not published
by FDA.
"grandfathered" and do
not require a 510(k).
Inventory and classification
Class III device notified to FDA prior to marketing
Good Manufacturing Practice (GMP) regulations

21. When You Can’t identify a predicate!!
• Clinical Study and PMA (Class III) (Premarket Approval)
– Quarter million dollar and 2 year process
– Novel, technology and high risk device
– sponsor must provide valid scientific evidence demonstrating reasonable assurance of
safety and effectiveness for the device’s intended use.
• De Novo Submission
– new device, without a valid predicate (Class I or II)
• Develop special controls guidance document
• How to be evaluated for performance, safety and efficacy?
– 510(k) exempt
• 510(k)(Premarket Notification)
• Pre-submission Meeting
– Product early stage of development, identify classification and predicate selection,
performance planning, etc.
• 513(g) submission
– Ask FDA to identify a predicate

22. Marketing Medical Device in US
• Medical devices marketed US are subject to
– the regulatory controls in the Federal Food, Drug, and Cosmetic Act
(FD&C Act) and
– the regulations in Title 21- Code of Federal Regulations (21 CFR) Parts
1-58, 800-1299.
– Medical devices that emit radiation are also subject to regulations for
radiation-emitting electronic products cited in 21CFR Parts 1000-1050.
• Premarket requirements
1. Classify Your Device
2. Choose the Correct Premarket Submission
3. Prepare Appropriate Information for Premarket Submission
4. Send Premarket Submission and Interact with FDA Staff during
Review
5. Complete the Establishment Registration and Device Listing

23. Process

24. Process

25. Process

26. Review

27. Marketing Medical Device in US
• Medical devices marketed US are subject to
– the regulatory controls in the Federal Food, Drug, and Cosmetic Act
(FD&C Act) and
– the regulations in Title 21- Code of Federal Regulations (21 CFR) Parts
1-58, 800-1299.
– Medical devices that emit radiation are also subject to regulations for
radiation-emitting electronic products cited in 21CFR Parts 1000-1050.
• Premarket requirements
1. Classify Your Device
2. Choose the Correct Premarket Submission
3. Prepare Appropriate Information for Premarket Submission
4. Send Premarket Submission and Interact with FDA Staff during
Review
5. Complete the Establishment Registration and Device Listing

28. Approval

29. Timelines

30. 3. 510(k) Submission Process
• Premarket Notification (510(k)submissions for
medical devices are reviewed by
– Center for Devices and Radiological Health (CDRH),
• Office of Device Evaluation (ODE) and
• Office of In Vitro Diagnostics and Radiological Health (OIR).
– The Divisions in these offices are organized according
to medical device specialties.
– biomedical engineers, physicians, microbiologists,
chemists, and other scientific professionals.

31. Timeline of
Communication during
510(k) Review
Acceptance review
•assess whether a
submission is
administratively complete
•RTA Hold-180days
•Substantive Review
Review of 510(k)
submission &
communication through
a Substantive Interaction
• Interactive Review
Resolve outstanding
deficiencies 90d
•AI Request-on hold 180d
Medical Device User Fee Agreement 2012
MDUFA Decision for a 510(k) is 90 FDA Days

32. 510(k) database
SE decision is considered "cleared." Adds to the 510(k) database, updated weekly

33. 510(k) database

34. RTA top 15 mistakes

35. How to Search for a Predicate Device
• “ Product Code Classification Database”
• “Classify Your Medical Device”
• Information which can be useful to find a predicate device includes:
– names of similar devices - traded name under which the device is
marketed;
– manufacturer(s) of the similar device(s);
– marketing status, i.e., pre-amendments or post-amendments device;
– 510(k) numbers for post-amendments devices;
– classification information, i.e., product codes, classifying regulations,
etc., for your device.
• 510(k) database
• FDA assigns a unique 3-letter product code or "procode" for each
generic category of device- best search

36. Product Classification
• Identify a similar device
• Use the registration and listing database
• Identify the 3-letter product code
• Click on the code product classification page
• Click on TPLC link

37. Example

38. Example

39. Example
• High Frequency Ventilator

40. TPLC - Total Product Life Cycle
Pareto of adverse events
Submissions received
Guidance

41. Example

42. Technological characteristics
• Materials
• Design
• Energy Source
• Other features
• Same ≠ Equivalent
– Does not raise DIFFERENT issues of safety or
effectiveness
– Must be as safe and effective as predicate

43. Split Predicates
• 1st Predicate has same intended use
• 2nd Predicate has same technological
characteristics
This is not allowed

44. Multiple Predicates allowed..
• Option 1:
– Two predicates with different technological
characteristics but the same intended use
• Option 2:
– A device with more than one intended use
• Option 3:
– More than one indication under the same
intended use

45. Example
• Laser hand piece
– Predicate A Er:YAG laser hand piece
– Predicate B Q-Switch Nd:YAG laser hand piece
– Both A & B predicates have the same general intended
use of lasers: incision, escision, ablation, vapourisation
of soft tissue
– New performance testing may be required
– A single predicate could have been used, but the
inclusion of a second predicate is helpful in
establishing substantial equivalence with regard to
specific indications and technological characteristics

46. Example
• Multi-parameter monitor
– New monitor includes different technologies-use
of infra-red..
– Predicate for each parameter-same intended use
– Monitoring of each parameter cannot interfere
with others
– New performance testing may be required

47. Equivalence Data
• Intended use
• Technological characteristics
– Material, design, energy source, other features
• Performance data-sections where details found,
list the documents
– Biocompatibility
– Electrical safety & Electromagnetic compatibility
– Software verification and validation
– Mechanical and acoustic testing
– Animal Study
– Clinical Study

48. Sections in a 510(k)
• Medical Device User Fee Cover
Sheet (Form FDA 3601)
• CDRH Premarket Review
Submission Cover Sheet
• 510(k) Cover Letter
• Indications for Use Statement
• 510(k) Summary or 510(k)
Statement
• Truthful and Accuracy Statement
• Class III Summary and
Certification
• Financial Certification or
Disclosure Statement
• Declarations of Conformity and
Summary Reports
• Executive Summary
• Device Description
• Substantial Equivalence
Discussion
• Proposed Labeling
• Sterilization and Shelf Life
• Biocompatibility
• Software
• Electromagnetic Compatibility
and Electrical Safety
• Performance Testing – Bench
• Performance Testing – Animal
• Performance Testing – Clinical
• Other

49. CDRH Premarket Review Submission
Cover Sheet
• Type of submission
• Applicant/ correspondent
• Product information
– Common or usual name or classification name
– Trade or Proprietary or Model Name for This Device
– Model Number
– FDA document numbers of all prior related submissions (regardless of
outcome)
– Data Included in Submission
• Laboratory Testing, Animal Trials, Human Trials
• Product Classification
• Manufacturing / Packaging / Sterilization Sites Relating To A Submission
• Utilization Of Standards
• Standards No., Standards Organization, Standards Title, Version Date

50. 510(k) Cover Letter
Administrative Information
– type of 510(k) submission
– device type in plain terms, i.e., by its common name;
– 510(k) submitter; contact person, by name, title, and phone number;
– preference for continued confidentiality (21 CFR 807.95);
– recommended classification regulation;
– class (i.e., whether it is unclassified or a class I, II, or III device).
– product code; and
– prior formal FDA document numbers
Basis for the Submission
– new device/ design/ indication for use/ modification of a legally
marketed device

51. 510(k) Cover Letter
• Design and Use of the Device (yes/no)
– Is the device intended for prescription use (21 CFR 801 Subpart D)?
– Is the device intended for over-the-counter use (21 CFR 807 Subpart C)?
– Does the device contain components derived from a tissue or other biologic
source?
– Is the device provided sterile?
– Is the device intended for single use?
– Is the device a reprocessed single use device?
– If yes, does this device type require reprocessed validation data?
– Does the device contain a drug?
– Does the device contain a biologic?
– Does the device use software?
– Does the submission include clinical information?
– Is the device implanted?

52. Indications for Use Statement
• Compare device’s indications for use (IFU)
statements to IFU of predicate device, including
any specific intended uses.
• The usual IFU for Full Field Digital
Mammography System (FFDM ) system is:
– The (device name) is indicated for generating
mammographic images that can be used for screening
and diagnosis of breast cancer.
– The (device name) is intended to be used in the same
clinical applications as traditional film/screen systems.
– incorporate diagnostic examples

53. 510(k) Summary
• 510(k) owner's & device’s details
• legally marketed device equivalence claimed
• description of device found in labeling or promotional material for device
– Incl. explanation of how device functions,
– scientific concepts forming basis for device,
– significant physical and performance characteristics
• device design, material used, and physical properties
• Intended use
– general description of diseases or conditions
– patient population for which device is intended.
– If indication statements different from predicate, explanation
• why differences are not critical to intended therapeutic, diagnostic prosthetic, or surgical
use
• Why differences do not affect safety and effectiveness of the device when used as
labeled

54. 510(k) Summary
• Summary of technological characteristics of device compared to predicate
• If determination SE based on non-clinical performance data
– discussion of nonclinical tests submitted, referenced, or relied
– how their results support a determination of substantial equivalence
• If determination SE based on clinical performance data
– discussion of clinical tests submitted, referenced, or relied
– how their results support a determination of SE
– description of subjects
– safety or effectiveness data
– specific reference to adverse effects and complications,
Clinical data is not needed for most devices cleared by the 510(k) process
• Conclusions drawn from nonclinical and clinical tests that demonstrate
device is as safe, as effective, and performs as well as or better than the
predicate device

55. Standards in SE Determinations
• FDA recognises more than 400 standards
– Manufacturers may use FDA-recognized standards
to meet 510(k) requirements by submitting :
• a declaration of conformity- data in files at time of
510(k) submission
• a statement-such data before a device is marketed
– Manufacturers may also use non-recognized
standards
• there is less assurance that these standards will be
acceptable.

56. Standards in SE Determinations

58. Executive Summary
• Concise description of device
– Incl. indications for use and technology
• Device comparison table-
– differences and similarities bet. device & predicate
– discussion of how this comparison supports SE
• Summary for performance testing
– type of testing performed, methods, conclusion

59. Device Description
• Performance specifications
• Device design requirements
• Identify all models, accessories, components
• Diagrams, dimensions, tolerances, schematics
• List of patient contacting components & their
respective materials

60. Substantial Equivalence Discussion
• Detailed comparison between the device and
predicate sufficient to demonstrate SE in
terms of:
– indications for use;
– technology; and
– performance specifications, including any testing.

63. Sec. 807.100 FDA action on a
premarket notification.
(b) FDA will determine that a device is substantially equivalent to a predicate device
using the following criteria:
(1) The device has the same intended use as the predicate device; and
(2) The device:
(i) Has the same technological characteristics as the predicate device; or
(ii)(A) Has different technological characteristics, such as a significant change in the
materials, design, energy source, or other features of the device from those of the
predicate device;
(B) The data submitted establishes that the device is substantially equivalent to the
predicate device and contains information, including clinical data if deemed
necessary by the Commissioner, that demonstrates that the device is as safe and
as effective as a legally marketed device; and
(C) Does not raise different questions of safety and effectiveness than the predicate
device.
(3) The predicate device has not been removed from the market at the initiative of
the Commissioner of Food and Drugs or has not been determined to be
misbranded or adulterated by a judicial order.
[57 FR 58403, Dec. 10, 1992, as amended at 63 FR 5253, Feb. 2, 1998]

64. Decision-Making
• Identify the new device and the predicate device.
• Decision 1 Is predicate device legally marketed? YES
• Review all labeling and assure that it is consistent
with IFU statements
• Decision 2 Do devices have same intended use? YES
• Review design, materials, energy source and other
features of the devices.
• Decision 3 Do the devices have the same
technological characteristics? Yes  SE
NO=NSE

65. Decision-Making
• NO Determine what questions of safety and
effectiveness the different technological characteristics
raise
• Decision 4 Do different technological characteristics
raise different questions of safety and effectiveness?
NO
• Review proposed scientific methods for evaluating
new/ different characteristics’ effects on safety and
effectiveness.
• Decision 5a Are the methods acceptable? YES
• Evaluate performance data
• Decision 5b Do the data demonstrate SE? YES SE

66. Proposed Labeling
• Copies of all proposed
– Labels-'display of written, printed, or graphic matter upon immediate
container of any article...'
– labeling, all labels and other written, printed, or graphic matter
• upon any article or any of its containers or wrappers, or
• accompanying such article' at any time while a device is held for sale after shipment or
delivery for shipment in interstate commerce
– package inserts,
– service manuals,
– instructions for use,
– advertising and/or promotional materials.
– directions for use
• a specific intended use statement
• warnings, contraindications, or limitations.
• Labeling should be final draft.
• Copies of labeling for predicate device(s) is recommended.

67. Sterilization and Shelf Life
• Sterilization method
• Sterilization site
• Dose in case of radiation sterilization
• Chemical: maximum levels of sterilant
residuals that remain on the device
• Method used to validate the sterilization cycle
• Sterility assurance level
• Pyrogenicity testing

68. Biocompatibility
• If device contains components that come into
direct or indirect contact with patients
• Evaluate biocompatibility of all patient tissue
contacting surfaces of device following ISO-
10993, Biological Evaluation of Medical
Devices Part 1: Evaluation and Testing
methodsor provide equivalent testing
information.

71. Software
• Level of concern: Failure / Flaw leading to injury
– Major Concern - death or serious injury
– Moderate Concern - minor injury
– Minor Concern - unlikely to cause any injury
• Software Description- features and operating environment
• Device Hazard Analysis
• Software Requirements Specification
• Architecture Design Chart
– functional units and software modules
– state diagrams as well as flow charts
• Software Design Specification

72. Software
• Traceability Analysis
– among requirements, specifications, identified hazards and
mitigations, and Verification and Validation testing
• Software Development Environment Description
– Summary of software life cycle development plan.
– List of control documents generated during development
process.
– Configuration management and maintenance plan documents.
• Verification and Validation Documentation
– V&V activities, integration, test protocols , pass/fail criteria, test
report, summary, and tests results
• Revision Level History
• Unresolved Anomalies(Bugs or Defects)

73. Electromagnetic Compatibility and
Electrical Safety
• If device design includes an electronic component ,
– evaluate its electromagnetic compatibility (EMC).
– EMC encompasses both
• emissions (interference with electronic products) and
• immunity (interference with device performance by emissions from other
electronic products).
• Test device according to
– IEC 60601-1- 2 Medical Electrical Equipment -- Part 1: General
Requirements for Safety;
– Electromagnetic Compatibility -- Requirements and Tests (Second
Edition, 2001)
• If device design results in patient contact with any electrically
powered component,
– Follow IEC 60601 1 (1988): Medical electrical equipment - Part 1:
General requirements for safety, including Amendment 1 (1991) and
Amendment 2 (1995) or an equivalent method.

74. Performance Testing – Bench/Animal
• List the specific bench tests conducted
• Describe each test protocol
– objective of the test
– test articles used in the test
– test methods and procedures (including any specific test
conditions)
– study endpoint, i.e., the specific parameter measured
– pre-defined acceptance or pass/fail criteria.
• Summarize the results
• Describe your analysis- clear and concise, table
• Discuss your conclusions
– comparison testing with predicate in terms of SE

75. Performance Testing – Bench/Animal
Bench testing
• ASTM testing methods
• Simulated use experiments
• Validated tools (known
input data for
software/hardware devices)
• Finite Element Analysis
• Cadaveric Studies
Animal Studies
• Rationales for reduction of
sample no. in order to spare
lives of animals
• Another 510(k) submission
that specifies no.
• Test more than once per
animal
• Small vs. large and duration

76. Performance Testing – Clinical
• 10-15% of submissions
• Objective of the test
• Test methods and procedures (including any specific test conditions)
• Study endpoints (usually both safety and effectiveness)
• Statistical methodology used.
• Study results, analyses performed (including statistical, as appropriate)
• Conclusions-comparison testing with predicate device in terms of SE.
• Study is considered significant risk, conducted under the IDE regulation,
21 CFR Part 812 if it is conducted in the United States
• If, however, study is considered non-significant risk, the study is subject to
the abbreviated requirements of 21 CFR Part 812.2(b) only.
• In all cases, sponsors of clinical trials must comply with regulations
governing institutional review boards (21 CFR Part 56) and informed
consent (21 CFR Part 50).

77. Steps in the PMA Application Process
• Filing review
• Statistical review for filing
• Review of manufacturing information for compliance
with the Quality System regulation (21 CFR 820).
• PMA filing decision
• Day-100 Meeting
• Quality System Inspection(s) by the FDA field
personnel.
• Bioresearch Monitoring (BIMO) Audit (audit of clinical
study data)

78. Steps in the PMA Application Process
• Substantive review coordination and completion in areas such as:
– Preparation of FDA Summary of Safety and Effectiveness Data (SSED)
– Nonclinical Studies
[Microbiological, Toxicological, Immunological, Biocompatibility, Shelf
Life, Analytical (for IVDs), Animal, Engineering (Stress, Wear, Fatigue,
etc.)]
– Clinical Studies
– Panel Meeting Decision and Mailing (if panel meeting is appropriate)
– Panel Date (if appropriate)
– Transcripts Received, Reviewed and Placed in Administrative Record
– QS/GMP Clearance
– Final Response from OC for GMP/BIMO
– Final ODE Decision Memo
– Approval Package
– Approval Order, SSED, Final Draft Labeling

79. POST MARKET SURVEILLANCE

80. • Manufacturers and importers must submit reports on
information that reasonably suggests that their marketed
devices may have
– caused or contributed to a death or serious injury or
– has malfunctioned
– the malfunction of the device or a similar device that they
market would be likely to cause or contribute to a death or
serious injury if the malfunction were to recur.
• Manufacturers must send reports of such deaths, serious
injuries and malfunctions to the FDA.
• Importers must send reports of deaths and serious injuries
to the FDA and the manufacturer, and reports of
malfunctions to the manufacturer.

81. MAUDE - Manufacturer and User
Facility Device Experience
• Each year, the FDA receives several hundred thousand
medical device reports (MDRs) of suspected device-
associated deaths, serious injuries and malfunctions.
• The FDA uses MDRs to monitor device performance,
detect potential device-related safety issues, and
contribute to benefit-risk assessments of these
products.
• The MAUDE database houses MDRs submitted to the
FDA by mandatory reporters (manufacturers, importers
and device user facilities) and voluntary reporters such
as health care professionals, patients and consumers.

82. MAUDE Adverse Event Report

83. MAUDE Adverse Event Report
VYAIRE MEDICAL, INC 3100 High Frequency Oscillatory Ventilator (HFOV) Ventilator, High
Frequency
Model Number 3100A
Device Problems Failure to cycle; Device operates differently than expected
Event Date 07/23/2017
Event Type Malfunction
Event Description
The customer reported that the amplitude setting dropped and the device stopped cycling. The
customer was unaware of any patient involvement and had no further information. The
customer reported requesting a Vyaire onsite service evaluation.
Manufacturer Narrative
Any additional information received from the customer will be included in a follow-up report. A
Vyaire field service representative (FSR) evaluated the device onsite. The FSR checked the
unit and found a faulty mean airway pressure (map) meter, which would display fluctuating
map readings. The FSR performed a two thousand hour (2k) preventative maintenance
procedure and other manufacture testing, which did not identify any other assembly failures.
Having passed all manufacture testing the device was return to the customer working to
specifications. At this time, the reported event was not duplicated however a map meter
failure was identified, which is not believed to be the cause of the reported event on this
complaint. No hardware return is expected or anticipated on this complaint therefore no
further investigation will be required.

85. MAUDE Adverse Event Report
• Bunnell, inc. Bunnell life pulse high frequency ventilator Bunnell life pulse HFV
• Model Number 203
• Device Problems Device stops intermittently; Device operates differently than expected
• Event Date 06/15/2017
• Event Type Malfunction
• Manufacturer Narrative
• The reported symptom of high pip with a ventilator fault could not be verified and was not
reproduced as reported. The self test always passed with no alarms of any type generated and the
system operated in a very stable manner with minimum fluctuations of all monitored values and no
alarm conditions of any type generated. The ventilator was found to be in near perfect calibration
condition and all monitoring, processing and control circuitry was verified to be operating correctly
and responding accurately. The hfv was thoroughly inspected, tested and serviced with no
problems found that could cause or be responsible for the reported symptoms. Systems operation
was very stable at a variety of controls pip and rate settings with no alarms in the hfv ready
condition. Hfv 2799 was fully serviced and passed all applicable testing requirements. Explanation
of reporting timeframe: bunnell was notified of this customer issue on 06/19/2017. Based on the
information received at that time it was determined that this was not a reportable event. Bunnell
received the suspect device on 06/26/2017 and completed an investigation of the issue. As this
investigation concluded that there were no issues with the device the event was not reported at
the time of the investigation. However, on 07/10/2017 bunnell received user facility report (b)(4).
The complaint file has been reviewed, and this report is being submitted within 30 days of bunnell
becoming aware of the user facility's determination of event reportability.

86. • Event Description
As stated in user facility report (b)(4): "ventilator
alarmed high pip (peak inspiratory pressure), self
cycled in an attempt to reset. Alarmed high pip
again and then shut down reading ventilator
fault. Patient was hand ventilated and suffered no
harm". As reported to bunnell: "we had a jet go
down while on patient, no patient injury. The jet
alarmed high pip twice and then ventilator fault.
The therapist turned off the jet and back on.
Would not test and indicated vent fault. ".

88. Limitation of MAUDE
• Passive surveillance system
– potential submission of incomplete, inaccurate, untimely, unverified,
or biased data.
– Incidence or prevalence of an event cannot be determined due to
• potential under-reporting of events
• lack of information about frequency of device use.
• Alone cannot be used to
– establish rates of events,
– evaluate a change in event rates over time or
– compare event rates between devices
– about the existence, severity, or frequency of problems associated
with devices

89. Limitation of MAUDE
• Cause-and-effect relationship difficult
– if circumstances surrounding event not verified or
– if the device in question not directly evaluated
• MAUDE search limited to reports of past 10 years.
• MAUDE data does not represent all known safety
information
• Variations in trade, product, and company names affect
search results.
• MAUDE is updated monthly and search page reflects
date of most recent update.
• Inclusion of some reports may be delayed.