BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDI-THERM III

    MDR report key: 7964968 · Received October 15, 2018

    Report

    Report Number
    7964968
    Event Type
    Malfunction
    Date Received
    October 15, 2018
    Date of Event
    February 11, 2018
    Report Date
    September 28, 2018
    Manufacturer
    GAYMAR INDUSTRIES, INC.
    Product Code
    DWJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WAS ON HYPOTHERMIA PROTOCOL. THE PATIENT HAD BEEN PLACED ON MEDITHERM III WRAPPING GARMENTS AND ALSO A COOLING BLANKET. UPON ARRIVAL FOR MY SHIFT, I NOTED THE PATIENT'S TEMPERATURE KEPT INCREASING STEADILY AND THE PATIENT WAS BOTH SHIVERING AND SWEATING. I ASSESSED THE PATIENT AND NOTED THE WRAPPING GARMENTS TO BE COLD. THE PATIENT FELT COOL. THE ROOM WAS VERY WARM AND I TRIED TO ADJUST THE THERMOSTAT. I NOTIFIED DOCTOR FOR ORDERS. WE CONSIDERED PARALYZING THE PATIENT AND DOING CULTURES. WHILE TURNING THE PATIENT AT 2045, I NOTED THE COOLING BLANKET UNDERNEATH THE PATIENT WAS PUTTING OUT EXTRAORDINARY AMOUNTS OF HEAT EVEN THOUGH IT WAS SET TO COOL AT 32 DEGREES. I ATTEMPTED TO TROUBLESHOOT THE BLANKET AND COULD NOT STOP IT FROM PUTTING OUT HEAT INSTEAD OF COLD, EVEN WHEN TURNING DOWN THE SETTINGS. THE RN CAME IN TO TROUBLESHOOTING TO NO AVAIL AS WELL. ANOTHER RN CAME TO HELP TROUBLESHOOTING AND SAID THEY HAD A PROBLEM WITH THE MACHINE THE PREVIOUS NIGHT; HEATING INSTEAD OF COOLING, BUT UPON TIGHTENING SOME CONNECTIONS, GOT IT TO COOL. I TURNED THE MACHINE OFF TO JUST USE THE WRAPPING GARMENTS TO CONTROL THE PATIENT'S TEMPERATURE. THE PATIENT'S TEMPERATURE CAME DOWN NICELY. DOCTORS CAME TO THE BEDSIDE AND WERE NOT PLEASED THAT WE HAD CONSIDERED EXTRA MEASURES BECAUSE OF THE MACHINE FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    806926 MEDI-THERM III SYSTEM, THERMAL REGULATING DWJ GAYMAR INDUSTRIES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 12045 DA