BEUDAMED
    FDA Adverse Event Death Summary report: N

    THERMOSUIT SYSTEM

    MDR report key: 2234191 · Received August 31, 2011

    Report

    Report Number
    3006059109-2011-00001
    Event Type
    Death
    Date Received
    August 31, 2011
    Date of Event
    August 1, 2011
    Manufacturer
    LIFE RECOVERY SYSTEMS HD, LLC
    Product Code
    NZE
    PMA / PMN Number
    K061023
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERMOSUIT SYSTEM THERMAL REGULATING SYSTEM NZE LIFE RECOVERY SYSTEMS HD, LLC TSP-50 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Death