THERMOSUIT SYSTEM

Description of Event or Problem

ON (B)(6) 2011, THE PT WAS BROUGHT TO AN OUTLYING HOSPITAL UNRESPONSIVE, APNEIC AND PULSELESS AFTER AN EXTENDED PERIOD OF CARDIAC ARREST. PT WAS TRANSPORTED BY SPOUSE. AFTER 40 MINS OF CPR THE PT RETURNED TO SPONTANEOUS CIRCULATION. THE PT WAS TRANSFERRED TO ANOTHER HOSPITAL VIA AIRLIFT AND WAS TAKEN DIRECTLY TO THE CATH LAB FOR SUCCESSFUL PCI. POST-RESUSCITATION THERAPEUTIC HYPOTHERMIA PER AHA GUIDELINES WAS PRESCRIBED. THE PT WAS POSTURING PRIOR TO COOLING. COOLING WAS INITIATED WITH THE THERMOSUIT SYSTEM WITH A TARGET PT TEMPERATURE OF 33 DEGREES C. THE PT WAS COOLED FOR APPROX 80 MINS, DURING WHICH THE PT TEMPERATURE DID NOT CHANGE ON THE THERMOSUIT SYSTEM. IT WAS DETERMINED THAT THE THERMOSUIT SYSTEM HAD MALFUNCTIONED AND DISPLAYED AN INACCURATE PT TEMPERATURE. ALTHOUGH THE THERMOSUIT SYSTEM DISPLAYED 39 DEGREES C, THE ACTUAL PT TEMPERATURE USING A DIFFERENT MONITOR WAS 28.5 DEGREES C. ACTIVE REWARMING WAS INITIATED. THE PT WENT INTO CARDIAC ARREST, THEN REC'D CPR, HOWEVER WAS UNRESPONSIVE. THE HOSPITAL PHYSICIANS INDICATED THAT THE CAUSE OF DEATH WAS THE UNDERLYING DISEASE AND PROLONGED PERIOD OF CARDIAC ARREST RATHER THAN THE PT OVER COOLING.

Additional Manufacturer Narrative

DEVICE IS MANUFACTURED FOR LIFE RECOVERY SYSTEMS BY SUBCONTRACT MFR, NEXCORE TECHNOLOGY, INC., (B)(4). DEVICE EVAL CONDUCTED BY NEXCORE.