D
Patient 1
PT. UNDERGOING EPS STUDY. V-TACH INDUCED. LIFE PAK 8 DEFIBRILLATOR CHARGED AT 200 JOULES TO ABORT V-TACH BUT WOULD NOT DISCHARGE. ATTEMPT MADE AT 360 JOULES WITH SAME RESULTS. EPS WAS UTILIZING DEFIB. "HANDS OFF" CASSETTE WITH USE OF R2 PADS. BIOMED WAS ABLE TO REPRODUCE PROBLEM AT 5 JOULES. LEAD SELECT WAS THEN HIT AND PUT ON PADDLES AND THEN ABLE TO DISCHARGE. SYNC LIGHT WAS NOT ACTIVATED DURING DISCHARGE. SUBSEQUENT TESTING HAD REVEALED UNIT ABLE TO DISCHARGE.INVALID 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: INVALID DATA. CORRECTIVE ACTIONS: NO DATA. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.