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Patient 1
ICU PATIENT DEVELOPED VENTRICULAR TACHYCARDIA, REQUIRED DEFIBRILLATION. AFTER THE FOURTH DEFIBRILLATION, THE EKG TRACING DISAPPEARED FROM THE SCREEN. THE DEFIBRILLATOR WAS IMMEDIATELY PLUGGED INTO THE NEAREST ELECTRICAL OUTLET AND EXHIBITED A DELAY IN RE-CHARGING. THE PATIENT REQUIRED NO FURTHER DEFIBRILLATION. THE DEFIBRILLATOR WAS REMOVED FROM PATIENT USE. BIOENGINEERING'S EVALUATION REVEALED A BATTERY PACK FAILURE AS THE DIRECT CAUSE OF THE DELAY IN RE-CHARGING. THE PATIENT SUBSEQUENTLY EXPIREDDEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: CRITICAL CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.DEVICE SERVICED IN ACCORDANCE WITH SERVICE SCHEDULE. DATE LAST SERVICED: 01-MAY-93. SERVICE PROVIDED BY: USER FACILITY BIOMEDICAL/BIOENGINEERING DEPARTMENT. SERVICE RECORDS AVAILABLE.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD. 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: COMPONENT FAILURE, BATTERY/PACK. CONCLUSION: DEVICE FAILURE DIRECTLY CAUSED EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: DEVICE TEMPORARILY REMOVED FROM SERVICE. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.