Description of Event or Problem · 1
PT IS A (B)(6) OLD, PREMATURE INFANT BORN AT 30 WEEKS GESTATION, WITH MILD BRONCHOPULMONARY DYSPLASIA WHO REQUIRED TO BE EVALUATED BY OUR HOSP FOR A RETINOPATHY OF PREMATURITY (RPO) EXAM AND CHOLESTASIS. OUR GROUND TRANSPORT TEAM WAS IN ROUTE TO PICK UP PT FROM AN OUTSIDE HOSP. IN THE BACK OF THE AMBULANCE, THE INTERNATIONAL BIOMED AVIATOR INCUBATOR WAS PLUGGED IN,EN ROUTE, TO WARM UP FOR TRANSPORTING THE INFANT. ON WAY TO THE REFERRING FACILITY, THE TRANSPORT TEAM SMELLED AN ELECTRICAL BURN COMING FROM THE BACK OF THE AMBULANCE. THE TEAM PULLED OVER, CHECKED THE BACK OF THE AMBULANCE TO FIND THE BURNING SMELL WAS COMING FROM THE ISOLETTE TRANSPORT BOX. THE TRANSFER WAS ABORTED DUE TO UNSAFE CONDITIONS FOR PT AND STAFF. THE INCUBATOR WAS RETURNED TO OUR BIOMED DEPT. BIOMED TURNED THE UNIT ON FOR ABOUT 20 MINS, NOTICING A DISTINCT ELECTRICAL BURNING SMELL COMING FROM THE EXHAUST FAN. BIOMED THEN OPENED THE INCUBATOR AND FOUND SMOKE COMING FROM THE MAIN POWER TRANSFORMER. AFTER INSTALLING THE NEW POWER TRANSFORMER, NO POWER WAS NOTED TO INCUBATOR SO BIOMED CHECKED COMPONENTS AND FOUND THE THERMISTOR SL-15003 PART WAS DEFECTIVE. BIOMED REPLACED THE THERMISTOR SL-15003, FURTHER TESTING NOTICED THAT THE THERMISTOR GOT HOT. BIOMED CALLED INTERNATIONAL BIOMED AND WAS TOLD IT WAS NORMAL FOR THE PART TO GET HOT. BIOMED THEN PERFORMED CALIBRATION AND ELECTRICAL SAFETY AND ALL TEST PASSED. THERE WAS NO HARM TO THE AMBULANCE STAFF. THE PT'S PROCEDURE WAS DELAYED. THERE WAS CONCERN THAT SIGNIFICANT PT (OR STAFF) HARM COULD HAVE OCCURRED IF OXYGEN HAD BEEN IN USE IN THE ENCLOSED ENVIRONMENT OF AN AMBULANCE DURING TRANSPORT OF THE INFANT IN THE ISOLETTE. FDA SAFETY REPORT ID# (B)(4).