Description of Event or Problem · 1
THE EMERGENCY CTR RNS WERE ATTEMPTING TO USE DEVICE ON AN 82-YR-OLD FEMALE WITH ACUTE THIRD DEGREE HEART BLOCK AND METABOLIC ACIDOSIS. THE PT'S HEART RATE WAS 38-40. THE DEVICE WAS SET FOR A RATE OF 70 BUT SHOWED THAT IT WAS SET FOR 40. THEREFORE, IT WOULD NOT PACE THE PT SINCE THE PT'S HEART RATE WAS ESSENTIALLY EQUAL TO THE DEVICE'S THRESHOLD SETTING. ALSO, THE MONITOR AT TIMES WAS SHOWING ASYSTOLE EVEN THOUGH THE PT HAD A HEART RATE. THE MONITOR AND DEFIBRILLATOR (CE-1754 AND 1757) ALONG WITH THE DEVICE WERE BROUGHT TO CLINICAL ENGINEERING FOR EVAL. THE MONITOR WAS FOUND TO HAVE A DAMAGED PT CABLE (INSULATION TORN, SHIELDING EXPOSED) WHICH WAS REPLACED. THE MONITOR AND DEFIBRILLATOR WERE TESTED OVER A PERIOD OF THREE DAYS WITH NO FAILURES AND THEN RETURNED TO SERVICE. THE DEVICE AND ITS ASSOCIATED CABLE TESTED OUT WITHIN SPECS, ALSO WITH NO FAILURES. HOWEVER, THE BPM ADJUSTMENT KNOB WAS FOUND TO BE VERY LOOSE, WITH A SPAN OF APPROX 10 BPM FOR ANY GIVEN SETTING. THESE DEVICES ARE NOT REPAIRABLE BY HOSP OR CO, THEY ARE REPLACED INSTEAD. A NEW ONE IS ON ORDER AT THIS TIME. 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-JUL-93. 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. RESULTS OF EVALUATION: MECHANICAL PROBLEM, TELEMETRY FAILURE, NONE OR UNKNOWN, RATE-MODULATED PACING SENSING FAILURE. CONCLUSION: DEVICE FAILURE OCCURRED AND WAS RELATED TO EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE PERMANENTLY REMOVED FROM SERVICE. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.