BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOTHERM

    MDR report key: 10905050 · Received November 25, 2020

    Report

    Report Number
    1516825-2020-00010
    Event Type
    Malfunction
    Date Received
    November 25, 2020
    Date of Event
    October 28, 2020
    Report Date
    November 25, 2020
    Manufacturer
    GENTHERM MEDICAL
    Product Code
    DWC
    UDI-DI
    10613031860221
    PMA / PMN Number
    K122813
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED A HEATING MALFUNCTION OCCURRED, THE DEVICE STOPPED HEATING NEAR THE END OF A SURGICAL CASE. THE DEVICE WAS SET AT 38 DEGREES, REACHED SET TEMP AT START OF CASE BUT THEN DROPPED AND WOULD NOT RISE TO SET POINT. THE CUSTOMER COULD NOT GET THE DEVICE TO HEAT ABOVE 30 DEGREES EVEN THOUGH THE HIGH AND LOW HEATING LED INDICATORS ARE ON. NO ADVERSE EVENT REPORTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A HEATING MALFUNCTION OCCURRED, THE DEVICE STOPPED HEATING NEAR THE END OF A SURGICAL CASE. THE DEVICE WAS SET AT 38 DEGREES, REACHED SET TEMP AT START OF CASE BUT THEN DROPPED AND WOULD NOT RISE TO SET POINT. THE CUSTOMER COULD NOT GET THE DEVICE TO HEAT ABOVE 30 DEGREES EVEN THOUGH THE HIGH AND LOW HEATING LED INDICATORS WERE ON. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1372255 HEMOTHERM HEATER/COOLER DWC GENTHERM MEDICAL 400CE 10613031860221

    Patients

    Seq Age Sex Outcome Treatment
    1