Description of Event or Problem · 1
MONITOR ALARM MALFUNCTIONED? NO AUDIBLE ALARM NOTED BY NURSING PERSONNEL FOR ASYSTOLE STATUS OF PATIENT. ALARM CONDITION OCCURING IN ROOM 8 AND THREE NURSES PRESENT AT BEDSIDE DID NOT HEAR ALARM OCCURING IN ROOM 206-0. NO MONITOR STRIPS GENERATED DURING PERIOD OF ASYSTOLE AND PT IN ROOM 206 DISCOVERED ASYSTOLIC. PATIENT EXPIRED POST CODE 99! PATIENT WAS 84 YEAR OLD MALE RECENT MI-POST CARDIAC CATHERIZATION WITH SEVERE MULTIPLE VESSEL DISEASE REQUIRING OPEN HEART SURGERY-WHICH PATIENT REFUSED TO HAVE PERFORMED. PATIENT STATUS CRITICAL PRIOR TO EVENT AND CARDIAC STATUS SEVERE DAMAGE AND INVOLVEMENTINVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. 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-APR-92. SERVICE PROVIDED BY: USER FACILITY BIOMEDICAL/BIOENGINEERING DEPARTMENT. SERVICE RECORDS AVAILABLE.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, COMPUTER SOFTWARE PERFORMANCE TESTS CONDUCTED, ELECTRICAL TESTS PERFORMED, PERFORMANCE TESTS PERFORMED. RESULTS OF EVALUATION: NONE OR UNKNOWN. CONCLUSION: DEVICE EVALUATED AND ALLEGED FAILURE COULD NOT BE DUPLICATED. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: DEVICE TEMPORARILY REMOVED FROM SERVICE. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.