BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOTHERM

    MDR report key: 10794516 · Received November 5, 2020

    Report

    Report Number
    1516825-2020-00009
    Event Type
    Malfunction
    Date Received
    November 5, 2020
    Date of Event
    October 9, 2020
    Report Date
    November 5, 2020
    Manufacturer
    GENTHERM MEDICAL
    Product Code
    DWC
    UDI-DI
    10613031860221
    PMA / PMN Number
    K122813
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER STATED THEY HAD THE DEVICE SET TO 36 AND THE SYSTEM WAS MEASURING 41 DEGREES. NO ADVERSE EVENT REPORTED. GENTHERM RECEIVED A COMPLAINT (SEE COMPLAINT #'S (B)(4)). (B)(4) IS BEING REPORTED UNDER A SEPARATE MDR # (1516825-2020-00008).

    Description of Event or Problem · 1

    CUSTOMER STATED THEY HAD THE DEVICE SET TO 36 AND THE SYSTEM WAS MEASURING 41 DEGREES. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1254728 HEMOTHERM HEATER/COOLER DWC GENTHERM MEDICAL 400CE 10613031860221

    Patients

    Seq Age Sex Outcome Treatment
    1