Description of Event or Problem · 1
ON 1/30/93 AT 1:52 PM, AN EMERGENCY HELICOPTER WAS ON ROUTE WITH PATIENT. PATIENT HAD AN EXTERNAL PACEMAKER AT A RATE OF 70 WITH GOOD CAPTURE. PATIENT'S BLOOD PRESSURE WAS 70/PALP. THE PATIENT HAD EARLIER EXPERIENCED A CARDIAC ARREST AND WAS UNRESPONSIVE. AT 2:10PM, THE PACEMAKER LOST CAPTURE AND AN INTRINSIC JUNCTIONAL RHYTHM WAS PRESENT. AT 2:20PM, THE PATIENT ARRIVED AT HER DESTINATION. DURING THE PAST TEN MUNUTES THE PATIENT'S BLOOD PRESSURE WAS BETWEEN 50-64/DOPPLER. FOLLOW-UP THE NEXT DAY FOUND THE PATIENT TO BE IN CRITICAL CONDITION.DEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: CRITICAL CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. DATE LAST SERVICED: 01-JAN-93. SERVICE PROVIDED BY: INVALID DATA. SERVICE RECORDS AVAILABLE.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD. INVALID DATA - WHETHER 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: BATTERY/PACK. CONCLUSION: DEVICE FAILURE INDIRECTLY CONTRIBUTED TO EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: NO DATA. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.