Description of Event or Problem · 1
THIS PACEMAKER WAS UTILIZED FOR THIS PATIENT FROM 1515 HOURS ON APRIL 23, 1992 UNTIL EVENT ON APRIL 26, 1992. FROM THE TIME OF INSERTION UNTIL THE INCIDENT THE PACEMAKER CAPTURED AND SENSED CORRECTLY. AT 0914 HOURS ON APRIL 26, 1992 THE PACEMAKER INITIATED AND SUSTAINED A VENTRICULAR TACHYCARDIA OF A RATE OF APPROXIMATELY 210, WHEN SET AT A RTE OF 70 BPM (RATE/MIN.). CPR WAS INITIATED IMMEDIATELY, THE EXTERNAL PACEMAKER TURNED OFF WITHIN 3-5 MINUTES OF INITIATION OF THE RHYTHM BUT CONTINOUS CPR FOLLOWING ACLS PROTOCOL AND APPLICATION OF A NEW EXTERNAL PACEMAKER WAS NOT ASSISTIVE IN THE SUCCESSFUL RESUSCITATION OF THE PATIENTDEVICE 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-MAR-92. SERVICE PROVIDED BY: USER FACILITY BIOMEDICAL/BIOENGINEERING DEPARTMENT. 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, PERFORMANCE TESTS PERFORMED, VISUAL EXAMINATION, OTHER. RESULTS OF EVALUATION: OTHER. CONCLUSION: INTERMITTENT FAILURE DIRECTLY CONTRIBUTED TO EVENT, DEVICE EVALUATED AND ALLEGED FAILURE COULD NOT BE DUPLICATED. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE PERMANENTLY REMOVED FROM SERVICE, USE OF ALL SIMILAR DEVICES STOPPED PERMANENTLY, INVALID DATA. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.