Description of Event or Problem · 1
ON APRIL 6, 1992, OUR SQUAD RESPONDED TO A CARDIAC FAILURE. THE PATIENT WAS DEFIBRILLATED THREE TIMES, ONCE AT 200 AND TWICE AT 300. THE TECHNICIAN INCREASED TO 360 AND ATTEMPTED A FORTH TIME. AT THAT TIME THE APEX PADDLE FLASHED A WHITE LIGHT AND MADE A LOUD NOISE. THE DEFIBRILLATOR COULD NOT BE TURNED ON. THERE WAS TOTAL LOSS OF POWER. A SECOND LIFE-PAK WAS THEN UTILIZED. AFTER EACH DEFIBRILLATION THE PATIENT'S EKG MONITOR NEVER DISPLAYED A NORMAL COMPLEX, INDICATING THAT SHE WAS NOT RESPONDING TO RESUSCITATION ATTEMPTSINVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: INVALID DATA. INVALID DATA - REGARDING MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD. INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED. INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT. METHOD OF EVALUATION: INVALID DATA. RESULTS OF EVALUATION: INVALID DATA. CONCLUSION: INVALID DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: UNKNOWN (CANNOT DETERMINE). CORRECTIVE ACTIONS: NO DATA. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.