1. Adverse Event Reports on Automatic External Defibrillators from 1996 - 2003 Oscar H Tovar MD and Beverly Gallauresi RN, MPH Food and Drug Administration Office of Surveillance and Biometrics Office of Device Evaluation

2. Medical Device Reporting Beverly Gallauresi RN, MPH Division of Postmarket Surveillance Office of Surveillance and Biometrics

3. 3 Oscar H Tovar CDRH / FDA/ DHHS MDR – A Brief Description ● Nationwide passive surveillance mandatory and voluntary reports ● Reporters manufacturers, importers user facilities voluntary ● Types of reports deaths serious injuries malfunctions

4. 4 Oscar H Tovar CDRH / FDA/ DHHS What is an Adverse Event ? An event whereby a medical device has, or may have, caused or contributed to a death or serious injury. Includes events associated with: - device failure- improper / inadequate design - device malfunction- manufacturing (problems) - use error- labeling (problems)

5. 5 Oscar H Tovar CDRH / FDA/ DHHS MAUDE Manufacturer and User Facility Device Experience

6. 6 Oscar H Tovar CDRH / FDA/ DHHS Methodology for Data Retrieval ● Product code ● August 1996 - December 2003

7. 7 Oscar H Tovar CDRH / FDA/ DHHS Manufacturer Reports August 1996 - December 2003 ● DEATH 590 ● INJURY 10 ● MALFUNCTION 7044 ● TOTAL 7644

8. 8 Oscar H Tovar CDRH / FDA/ DHHS Limitations of MDR ● Underreporting ● No incidence data ● Biased reporting ● Uncertain causality

9. Oscar H Tovar MD Food and Drug Administration Office of Device Evaluation Office of Surveillance and Biometrics

10. 10 Oscar H Tovar CDRH / FDA/ DHHS ● The benefits of early defibrillation in public places have been shown in numerous studies ● There is a steady increase in deployment of automatic external defibrillators (AEDs) ● The estimated AED growth rate for the USA was 8.2% for 2000 and 2001, 11.5% for 2002 and 22.0% for 2003. It is estimated to be about 20% per year in the next 5 years* * Frost & Sullivan, September 2003 Background

11. 11 Oscar H Tovar CDRH / FDA/ DHHS ● The success of early defibrillation implies that the AED works in the first attempt and consistently in the following attempts if necessary ● An AED failure to deliver a defibrillation shock decreases significantly the probability of survival of a patient in ventricular fibrillation ● There is scarce information about adverse events associated with AED use Background

12. 12 Oscar H Tovar CDRH / FDA/ DHHS Goals of the Study To assess adverse event reports – particularly deaths- associated with AED failure from 1996 to 2003 To determine AED component failure or factors that resulted in failed defibrillation associated with deaths

13. 13 Oscar H Tovar CDRH / FDA/ DHHS ● We reviewed Medical Device Reports (MDR) submitted by AED manufacturers to the FDA for AED-related adverse events. ● MDRs were received from 8-19-1996 to 12-31-2003. ● We analyzed MDRs using the Manufacturer and User Facility Device Experience (MAUDE) database from the FDA. Methods

14. 14 Oscar H Tovar CDRH / FDA/ DHHS Methods ● The manufacturer results and conclusion codes (following failure analyses) were used to assess the association of device and component failure with a patient death. Both results and conclusions were grouped in categories.

15. 15 Oscar H Tovar CDRH / FDA/ DHHS Adverse Events 1996-1999

16. 16 Oscar H Tovar CDRH / FDA/ DHHS Adverse Events 2000-2003

17. 17 Oscar H Tovar CDRH / FDA/ DHHS Adverse Events 2000-20031996-1999

18. 18 Oscar H Tovar CDRH / FDA/ DHHS AED Malfunctions 1996-2003

19. 19 Oscar H Tovar CDRH / FDA/ DHHS AED Injuries 1996-2003

20. 20 Oscar H Tovar CDRH / FDA/ DHHS AED-Associated Deaths

21. 21 Oscar H Tovar CDRH / FDA/ DHHS Manufacturers’ Conclusions 1996-1999 Percent

22. 22 Oscar H Tovar CDRH / FDA/ DHHS Manufacturers’ Conclusions 2000-2003 Percent

23. 23 Oscar H Tovar CDRH / FDA/ DHHS Manufacturers’ Conclusions 1996-2003 2000-2003 1996-1999 Percent

24. 24 Oscar H Tovar CDRH / FDA/ DHHS Component Failure 1996-1999 Percent

25. 25 Oscar H Tovar CDRH / FDA/ DHHS Component Failure 2000-2003 Percent

26. 26 Oscar H Tovar CDRH / FDA/ DHHS Component Failure 1996-2003 2000-2003 1996-1999 Percent

27. 27 Oscar H Tovar CDRH / FDA/ DHHS AED Recalls 1996-2003

28. 28 Oscar H Tovar CDRH / FDA/ DHHS Conclusions The results suggest that: ● The number of reported deaths associated with AED failure is markedly more frequent than injuries ● Reported AED failure is increasing, along with increase in AED deployment

29. 29 Oscar H Tovar CDRH / FDA/ DHHS Conclusions ● There is a relative decrease in reported electrical component failure ● There is relative decrease in reported device operation outside specifications (which includes use error)