Description of Event or Problem · 1
INFANT WAS FOUND UNDER RADIANT WARMER WITH SKIN TEMPERATURE OF 41 DEGREES CENTIGRADE AND AXILLARY TEMPERATURE OF 38 DEGREES CENTIGRADE. THE WARMER WAS IN "MANUAL" MODE. NURSES STATE THAT THE WARMER DID NOT ALARM AS IT SHOULD HAVE AFTER 15 MINUTES. THE INFANT EXPIRED TWO DAYS LATER AND IT IS UNCERTAIN IF THE DEATH IS RELATED TO ITS OVERHEATING. ADDITIONAL EQUIPMENT IN USE AT THE TIME INCLUDES THE FOLLOWING: CARDIO-PULMONARY MONITOR, PLUSE OXIMETER AND A BEAR CUB VENTILATORDEVICE 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-AUG-91. 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, 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. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.