Description of Event or Problem · 1
PATIENT HAD A PERMANENT PACEMAKER WHICH LOST CAPTURE. RESUSCITATION BEGAN. TRANSTHORACIC PACEMAKER APPLIED, PACER CASSETTE FAILED TO COME ON. PERMANENT PACEMAKER BEGAN TO CAPTURE. PATIENT EXPIRED. IT IS NOT FELT FAILED PACER CASSETTE CONTRIBUTED TO DEATH OF PATIENT. HOWEVER, FAILURE OF THIS TYPE HAS THE POTENTIAL TO CONTRIBUTE TO DEATH OF A PATIENT AND IS THEREFORE BEING REPORTED.DEVICE 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-NOV-91. 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, MECHANICAL TESTS PERFORMED, PERFORMANCE TESTS PERFORMED, VISUAL EXAMINATION. RESULTS OF EVALUATION: ELECTRICAL PROBLEM - OPEN CIRCUIT. CONCLUSION: DEVICE FAILED JUST PRIOR TO USE. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: DEVICE RETURNED TO MANUFACTURER/DEALER/DISTRIBUTOR. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.