Description of Event or Problem · 1
PT WITH CARDIAC ARREST/RESPIRATORY ARREST CODE IN PROGRESS. MONITOR WORKING THEN MADE A NOISE, THE SCREEN FADED OUT AND IT WOULD NOT PRINT. PT SUBSEQUENTLY EXPIRED DUE TO PT'S CRITICAL CONDITION AND NOT DUE TO THE MONITOR NOT WORKING. EQUIPMENT WAS IMMEDIATELY TAKEN TO BIO-MED ENGINEER WITH APPROPRIATE TESTS PERFORMED. EQUIPMENT PERFORMED AS DESIGNED WHILE HOOKED TO A LIVING EMPLOYEE. NO FURTHER PROBLEMS OCCURRED. NO EVIDENCE OF WHAT COULD HAVE CAUSED THE EARLIER DEVICE FAILURE COULD BE DETERMINED.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-MAY-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: NONE OR UNKNOWN. CONCLUSION: DEVICE EVALUATED AND ALLEGED FAILURE COULD NOT BE DUPLICATED. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: NO. CORRECTIVE ACTIONS: INSERVICED BY BIOMEDICAL ENGINEERING DEPT. STAFF. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.