Description of Event or Problem · 1
ON MAY 26, 1993 AT 9:45 PM THE PATIENT INVOLVED WAS EXHIBITING CHANGES IN HGER TELEMETRY MONITOR PATTERN. SHE HAD BEEN IN SUPRAVENTRICULAR RYTHUM OF APPROX. 150 BMP. HER RATE SLOWED TO 91 AND THEN TO 69 WITH WIDENING OF THE QRS COMPLEX. THE NURSES WERE WITH HER AND SHE BECAME UNRESPONSIVE. HER WIDENING OF THE QRS COMPLEX WAS CONSIDERED TO HAVE PROGRESSED TO EMD (ELECTOMECHANICAL DYSFUNCTION) WHICH IS A LETHAL RYTHUM BECAUSE THE ELECTRICAL IMPULSE DOES NOT STIMULATE AND CARDIAC MUSCLE CONTRACTION.THE DEFIBRILLATOR HAD BEEN CHECKED EARLIER IN THE SAME SHIFT AND FUNCTIONED PROPERLY. IT WAS CHARGED AND DISCHARGED INTO THE PATIENT. AT THIS TIME THE DEFIBRILLATOR WENT BLANK AND WOULD NOT FUNCTION AT ALL. AST THIS TIME OTHER ALTERNATIVE MEASURES WERE TAKEN AND ANOTHER DEFIBRILLATOR WAS OBTAINED.THE PATIENT WAS IN CRITICAL CONDITION PRIOR TO CODE AND DID EXPIRE AT 10:30 P.M.ENGINEERING WAS CALLED TO EVALUATE THE PROBLEM WITH THE DEFIBRILLATOR. IT WAS DETERMINED THAT THIS EVENT COULD NOT HAVE BEEN PREDICTED. THE INTERNAL HAD LEAKED AND WAS DESTROYED WITH THE DISCHARGE THE PATIENT RECEIVED. THE BATTERY WAS REPLACED AND THE DEFIBRILLATOR IS NOW BACK IN USEDEVICE 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-FEB-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: BATTERY/PACK. CONCLUSION: DEVICE FAILURE OCCURRED AND WAS RELATED TO EVENT, OTHER. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: NO. CORRECTIVE ACTIONS: DEVICE REPAIRED AND PUT BACK IN SERVICE, OTHER. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.