Description of Event or Problem · 1
WHILE DOING A CARDIAC CATH, SEVERE WEATHER, HIGH WINDS, AND LIGHTENING OCCURRED CAUSING ELECTRICAL SHORTAGE, AND THE CATH EQUIPMENT WENT DOWN, EQUIPMENT STILL WOULDN'T COME UP WHILE ON ALTERNATE POWER, ONLY THE RIGHT HEART CATH WAS DONE. THE PATIENT RETURNED TO ROOM, 40 MINUTES LATER HAD INCREASING CHEST PAIN. IT WAS DETERMINED BY EKG THAT THE PATIENT HAD EXTENDED HIS MYOCARDIAL INFARCTION. GENERAL ELECTRIC TECHNICIAN REPLACE A TRANSISTOR AND 2 FUSES THAT BLEW DURING THE STORM. OTHER DEVICES IN USE AT THE TIME OF THE OCCURENCE:GENERAL ELECTRIC PA GENERATOR, MEDDARS PHYSIOCONTROL PPG EVR MONITOR AND A MEDRAD INJECTOR-MEDRAD COMPANYDEVICE 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-DEC-91. SERVICE PROVIDED BY: DISTRIBUTOR. SERVICE RECORDS AVAILABLE.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ELECTRICAL TESTS PERFORMED, MECHANICAL TESTS PERFORMED, PERFORMANCE TESTS PERFORMED. RESULTS OF EVALUATION: ELECTRICAL PROBLEM, NONE OR UNKNOWN, ENVIRONMENTAL FACTORS, POWER LOSS/SURGE RELATED COMPLICATION. CONCLUSION: DEVICE FAILURE INDIRECTLY CONTRIBUTED TO EVENT, NONE OR UNKNOWN. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: MAYBE. CORRECTIVE ACTIONS: DEVICE REPAIRED AND PUT BACK IN SERVICE. THE DEVICE WAS DESTROYED/DISPOSED OF.