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Adverse Event Reports on Automatic External Defibrillators from 1996 - 2003

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. Medical Device Reporting. Beverly Gallauresi RN, MPH

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Adverse Event Reports on Automatic External Defibrillators from 1996 - 2003

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  1. Adverse Event Reportson 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. MDR – A Brief Description • Nationwide passive surveillance • mandatory and voluntary reports • Reporters • manufacturers, importers • user facilities • voluntary • Types of reports • deaths • serious injuries • malfunctions CDRH / FDA/ DHHS

  4. 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) CDRH / FDA/ DHHS

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

  6. Methodology for Data Retrieval • Product code • August 1996 - December 2003 CDRH / FDA/ DHHS

  7. Manufacturer ReportsAugust 1996 - December 2003 • DEATH 590 • INJURY 10 • MALFUNCTION 7044 • TOTAL 7644 CDRH / FDA/ DHHS

  8. Limitations of MDR • Underreporting • No incidence data • Biased reporting • Uncertain causality CDRH / FDA/ DHHS

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

  10. Background • 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 CDRH / FDA/ DHHS

  11. Background • 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 CDRH / FDA/ DHHS

  12. 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 CDRH / FDA/ DHHS

  13. Methods • 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. CDRH / FDA/ DHHS

  14. 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. CDRH / FDA/ DHHS

  15. Adverse Events 1996-1999 CDRH / FDA/ DHHS

  16. Adverse Events 2000-2003 CDRH / FDA/ DHHS

  17. Adverse Events 1996-1999 2000-2003 CDRH / FDA/ DHHS

  18. AED Malfunctions 1996-2003 CDRH / FDA/ DHHS

  19. AED Injuries 1996-2003 CDRH / FDA/ DHHS

  20. AED-Associated Deaths CDRH / FDA/ DHHS

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

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

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

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

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

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

  27. AED Recalls 1996-2003 CDRH / FDA/ DHHS

  28. 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 CDRH / FDA/ DHHS

  29. 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) CDRH / FDA/ DHHS

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