Description of Event or Problem · 1
DURING THE FIRST CODE EVENT, THE DEFIBRILLATOR DISCHARGED AT 300 JOULES. IN THE SECOND CODE EVENT, DURING ATTEMPTED DEFIBRILLATION, THE PADDLES WOULD NOT DISCHARGE AT 300 JOULES. THE CHARGE BUTTON HAD BEEN ACTIVATED, THE DEFIBRILLATOR WAS PLUGGED IN AND THE PT WAS BEING MONITORED VIA ANESTHESIA MONITOR, NOT DEFIBRILLATOR MONITOR. IT WAS NOTED THAT THE SYNC MODE LIGHT CAME ON OR HAD BEEN ACTIVATED. DISCHARGE FAILED. THE SYNC MODE WAS DEACTIVATED AND DEFIBRILLATOR THEN DISCHARGED AT 300 JOULES. THE UNIT WAS REMOVED FROM AREA AND A COMPLETE SAFETY AND FUNCTION TEST WAS PERFORMED. THE ROUTINE OR STAFF TESTING ON DEFIBRILLATOR HAD BEEN COMPLETED IN THE AM THE DAY OF THE INCIDENT.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.DEVICE SERVICED IN ACCORDANCE WITH SERVICE SCHEDULE. DATE LAST SERVICED: 01-MAY-96. SERVICE PROVIDED BY: INDEPENDENT FACTORY TRAINED/AUTHORIZED SERVICE ORGANIZATION. SERVICE RECORDS AVAILABLE.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, ELECTRICAL TESTS PERFORMED, MECHANICAL TESTS PERFORMED, PERFORMANCE TESTS PERFORMED. RESULTS OF EVALUATION: NONE OR UNKNOWN, INCORRECT TECHNIQUE/PROCEDURE, UNANTICIPATED ADVERSE REACTION - LONG TERM. CONCLUSION: DEVICE EVALUATED AND ALLEGED FAILURE COULD NOT BE DUPLICATED, NONE OR UNKNOWN. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: DEVICE TEMPORARILY REMOVED FROM SERVICE. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.