Description of Event or Problem · 1
PATIENT HAD CARDIAC ARREST IN ROOM. DURING RESUSCITATION EFFORTS, LIFEPAK 9P WAS USED. MA WOULD NOT ADJUST, THEREFORE EXTERNAL PACEMAKER WOULD NOT CAPTURE. REPLACEMENT LIFEPAK 9P IMMEDIATELY OBTAINED FROM ANOTHER NURSING UNIT AND USED ON PATIENT. PATIENT EXPIRED. INQUIRES MADE OF PHYSCIAN DURING COMMITTEE INVESTIGATION OF INCIDENT AS TO EFFECT OF EQUIPMENT FAILURE ON OUTCOME OF CODE. PHYSCIAN SATES EVENT WAS UNRELATED TO OUTCOMEDEVICE 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: INDEPENDENT FACTORY TRAINED/AUTHORIZED SERVICE ORGANIZATION. 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, ELECTRICAL TESTS PERFORMED, PERFORMANCE TESTS PERFORMED. RESULTS OF EVALUATION: COMPONENT FAILURE, OTHER. CONCLUSION: DEVICE FAILURE OCCURRED BUT NOT RELATED TO EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: NO. CORRECTIVE ACTIONS: DEVICE PERMANENTLY REMOVED FROM SERVICE, DEVICE RETURNED TO MANUFACTURER/DEALER/DISTRIBUTOR. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.