BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOTHERM

    MDR report key: 15077911 · Received July 21, 2022

    Report

    Report Number
    1516825-2022-00004
    Event Type
    Malfunction
    Date Received
    July 21, 2022
    Date of Event
    May 23, 2022
    Report Date
    June 23, 2022
    Manufacturer
    GENTHERM MEDICAL, LLC
    Product Code
    DWC
    PMA / PMN Number
    K122813
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    FDA REPORT, MW5110281, RECEIVED BY GENTHERM MEDICAL, LLC ON 6/23/2022. THE CUSTOMER WISHES TO REMAIN ANONYMOUS. GENTHERM IS UNABLE TO ATTEMPT TO RETRIEVE THIS DEVICE FOR EVALUATION AS A RESULT.

    Description of Event or Problem · 0

    WHILE PATIENT WAS IN OPEN HEART SURGERY HIS TEMPERATURE COULD NOT BE MAINTAINED AND IT WAS DISCOVERED THAT THE HEMOTHERM MACHINE WAS NOT FUNCTIONING/NOT HEATING. IT WAS DISCOVERED THAT THE MACHINE HAD A FAULTY HEATING ELEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242268 HEMOTHERM HEMOTHERM DWC GENTHERM MEDICAL, LLC 400CE

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown