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Patient 1
THE REPORTED EVENT WAS CONFIRMED AS A DEFECTIVE CIRCULATION PUMP. THE SERIAL NUMBER FOR THE DEVICE ASSOCIATED WITH THIS PARTICULAR EVENT(SERIAL NUMBER (B)(4): DATE OF MANUFACTURE: 01/2011) THAT WAS IN USE AT THE TIME THIS EVENT OCCURRED UNDERWENT A MANUFACTURING REVIEW AND THE DEVICE HISTORY RECORDS FOUND NOTHING THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE INSTRUCTIONS FOR USE WERE FOUND ADEQUATE AND STATE THE FOLLOWING: "WARNINGS DO NOT USE THE ARCTIC SUN? TEMPERATURE MANAGEMENT SYSTEM IN THE PRESENCE OF FLAMMABLE AGENTS BECAUSE AN EXPLOSION AND/OR FIRE MAY RESULT. DO NOT USE HIGH FREQUENCY SURGICAL INSTRUMENTS OR ENDOCARDIAL CATHETERS WHILE THE ARCTIC SUN? TEMPERATURE MANAGEMENT SYSTEM IS IN USE. THERE IS A RISK OF ELECTRICAL SHOCK AND HAZARDOUS MOVING PARTS. THERE ARE NO USER SERVICEABLE PARTS INSIDE. DO NOT REMOVE COVERS. REFER SERVICING TO QUALIFIED PERSONNEL. POWER CORD HAS A HOSPITAL GRADE PLUG. GROUNDING RELIABILITY CAN ONLY BE ACHIEVED WHEN CONNECTED TO AN EQUIVALENT RECEPTACLE MARKED ?HOSPITAL USE? OR ?HOSPITAL GRADE?. WHEN USING THE ARCTIC SUN? TEMPERATURE MANAGEMENT SYSTEM, NOTE THAT ALL OTHER THERMAL CONDUCTIVE SYSTEMS, SUCH AS WATER BLANKETS AND WATER GELS, IN USE WHILE WARMING OR COOLING WITH THE ARCTIC SUN? TEMPERATURE MANAGEMENT SYSTEM MAY ACTUALLY ALTER OR INTERFERE WITH PATIENT TEMPERATURE CONTROL. DO NOT PLACE ARCTICGEL? PADS OVER TRANSDERMAL MEDICATION PATCHES AS WARMING CAN INCREASE DRUG DELIVERY, RESULTING IN POSSIBLE HARM TO THE PATIENT."