[4152]
24 year old hospital employee without apparent medical history sustained cardiac arrest. Ekg showed v-fib. Defibrillator failed to discharge; low battery light noted. Machine plugged into outlet and again failed to discharge. Another defibrillator utilized. Junctional rhythm restored and continued. Patient transferred to ccu and subsequently expired. Defibrillator in question removed from patient use and sent to bioengineering. Evaluation revealed: worn energy switch; battery charger board-incapable of charging it battery is low and unit is plugged into outlet. This battery charger borad has been upgraded. The battery was tested and found without defectsdevice not labeled for single use. Patient medical status prior to event: critical condition. There was not multiple patient involvement. Device not serviced in accordance with service schedule. Date last serviced: 01-oct-92. Service provided by: user facility biomedical/bioengineering department. Service records available. Invalid data - regarding whether event presents imminent hazard. Invalid data - whether device used as labeled/intended. Device was evaluated after the event. Method of evaluation: actual device involved in incident was evaluated, electrical tests performed, performance tests performed. Results of evaluation: electrical problem, modification of device. Conclusion: device failure occurred and was related to event. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: device temporarily removed from service, user education provided. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5