BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMASOLUTIONS, INC.

    MDR report key: 6269558 · Received January 20, 2017

    Report

    Report Number
    MW5067378
    Event Type
    Malfunction
    Date Received
    January 20, 2017
    Date of Event
    January 17, 2017
    Report Date
    January 19, 2017
    Manufacturer
    THERMASOLUTIONS, INC.
    Product Code
    MLW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    TEMPERATURE SENSOR ERROR DURING SET-UP. VENDOR DISCOVERED CORROSION ON INTERNAL THERMOSTAT LOCATED IN WATER RESERVOIR. SURGERY COULD NOT BE COMPLETED DUE TO MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49451 THERMASOLUTIONS, INC. THERMOCHEM HT-1000 MLW THERMASOLUTIONS, INC. MT-1000

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other