1. ©ECRI 2007 1 XXI. Defibrillators TRAINING SEMINAR ON MEDICAL DEVICE ACCIDENT INVESTIGATION for Kingdom of Saudi Arabia Saudi Food & Drug Authority Riyadh 11-14 February, 2007 Presenter: Mark E. Bruley Vice President, Accident and Forensic Investigation ECRI 5200 Butler Pike, Plymouth Meeting, PA, 19642 USA Tel: +1 610-825-6000, ext. 5223 E-mail: mbruley@ecri.org Web Sites: www.ecri.org www.mdsr.ecri.org

2. ©2007 ECRI 2 Defibrillators “Failed to Discharge” Scenario Performance Testing Safety in Testing Battery Considerations Patient Considerations Patient Chest Burns Patient Fires

3. ©2007 ECRI 3 “Failed to Discharge” Scenario Case 3: Tried to defib several times with no effect; used another defib. What actually happened? Was battery charged? Was unit set properly? Did unit fail somehow? Were paddles or pads used?

4. ©2007 ECRI 4 Performance Testing Does it work? –Battery good for 10 discharges at max. energy –Electrically safe –Proper output energy –Proper paddles or pads

5. ©2007 ECRI 5 Safety in Testing Discharge to test device Careful placement of hands Have a buddy present

6. ©2007 ECRI 6 Battery Considerations Battery explosion Overheating/Too cold Insufficient power/Not charged

7. ©2007 ECRI 7 Patient Considerations Proper pad/paddle placement? Pad in good shape? Pacemaker present?

8. ©2007 ECRI 8 Patient Chest Burns Paddle or pads not in good contact Arc strike

9. ©2007 ECRI 9 Patient Fires Oxygen in use Defib provides spark Surface fiber flame propagation in hair

10. ©2007 ECRI 10 QUESTIONS? XXI. Defibrillators