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Adverse Event Reports for External Defibrillators 2005 – 2010

Adverse Event Reports for External Defibrillators 2005 – 2010. Roberta Sullivan, BSN, MPH Nurse Consultant, MDR Analyst Office of Surveillance and Biometrics Division of Postmarket Surveillance Product Evaluation Branch I. Introduction. Medical Device Report (MDR) Mandatory - Form 3500A

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Adverse Event Reports for External Defibrillators 2005 – 2010

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  1. Adverse Event Reportsfor External Defibrillators 2005 – 2010 Roberta Sullivan, BSN, MPH Nurse Consultant, MDR Analyst Office of Surveillance and Biometrics Division of Postmarket Surveillance Product Evaluation Branch I AED/DPS-12/15/10-RXS

  2. Introduction • MedicalDevice Report (MDR) • Mandatory - Form 3500A • Voluntary MedWatch - Form 3500 • Manufacturer and User Facility Device Experience (MAUDE) • http://www.fda.gov/Safety/MedWatch/HowToReport/default.htm • Or go to www.fda.gov -> navigate to “report a problem” online AED/DPS-12/15/10-RXS

  3. MDRs: Received by FDA from Jan 1, 2005 to Jan 1, 2010 • Original Product Code LDD: dc-defibrillator, low-energy, (including paddles) Class II, 510K cleared * ExternalDefibrillator, rhythm not diagnosed nor shock delivered automatically • Subsequent Product code MKJ: automated or semi-automated external defibrillators Class III, 510K cleared, used by lay public *Automatic functions, AED AED/DPS-12/15/10-RXS

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  8. Patient problem codes • No patient involvement (59%) • No patient consequences (10%) • Unknown (9%) • Not applicable (5%) • No information (5%) • Death (4%) • No known impact to patient (3%) • Resuscitation (<1%) • Hospitalization required (<1%) • Cardiac Arrest (<1%) AED/DPS-12/15/10-RXS

  9. Patient problem codes • No patient involvement (59%) • No patient consequences (10%) • Unknown (9%) • Not applicable (5%) • No information (5%) • Death (4%) • No known impact to patient (3%) • Resuscitation (<1%) • Hospitalization required (<1%) • Cardiac Arrest (<1%) AED/DPS-12/15/10-RXS

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  11. Device problem codes • Device displays error message (28%) • Failure to power up (15%) • Failure to charge, discharge or deliver (9%) • Loss of power (4%) • No display or display failure (4%) • Replace (4%) • Failure to run on AC/DC (3%) • Failure to shock or pace properly (3%) • Device issue (2%) • Device inoperable (2%) AED/DPS-12/15/10-RXS

  12. If returned for analysis, the evaluation identified device failure 1 time out of 3 (Component/subassembly failure, electrical/mechanical problem, design, contamination, manufacturing, software) • If returned for analysis, the conclusion was “device failure directly caused event or was related to event” ~40% of time AED/DPS-12/15/10-RXS

  13. What can MDR information be used for? • Provide a qualitative snapshot of adverse events for a specific device or device type • Signal detection • Unexpected events for a specific device type • Change in severity of expected events • User error/human factors issues • Regulatory actions • Premarket considerations • Public health communications AED/DPS-12/15/10-RXS

  14. Example 1 • “Complaint alleged that while attempting to cardiovert a pt (age and gender unknown), the device inappropriately shut down. Complainant indicated that the patient subsequently expired”. AED/DPS-12/15/10-RXS

  15. Example 2 • “Person requiring CPR, which was started by first responders. Nurse team arrived with AED, continued CPR, placed pads and hooked up to AED. Reading said "MEMORY FULL." CPR continued. Paramedics arrived with ambulance, took over CPR, intubated, inserted IV and transported to hospital. Placed on monitor en route, flatline. Pronounced upon arrival” AED/DPS-12/15/10-RXS

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  17. Postmarket Surveillance • We need your reports for postmarket surveillance! • www.fda.gov for how to report and to access MAUDE MDR database AED/DPS-12/15/10-RXS

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