BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOPHORE AUTOMATIC MOIST HEAT PACK

    MDR report key: 3131459 · Received February 25, 2013

    Report

    Report Number
    1811605-2013-00022
    Event Type
    Malfunction
    Date Received
    February 25, 2013
    Date of Event
    February 12, 2013
    Report Date
    February 18, 2013
    Manufacturer
    BATTLE CREEK EQUIPMENT COMPANY
    Product Code
    IRT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE UNIT REMAINED "ON" WHENEVER IT WAS PLUGGED IN, EVEN WHEN THE POWER BUTTON WAS NOT ACTIVATED OR THE OFF BUTTON WAS PUSHED. OUR INVESTIGATION REVEALED A DEFECT IN THE POWER CONTROL. WE WILL FOLLOW UP WITH OUR SUPPLIER TO DETERMINE THE CAUSE OF THIS MALFUNCTION.

    Description of Event or Problem · 1

    THE USER REPORTED THAT THE SWITCH STAYED ON. OUR INVESTIGATION CONFIRMS THAT THE SWITCH DOES NOT SHUT OFF AND WE WERE UNABLE TO DETERMINE THE CAUSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    81153 THERMOPHORE AUTOMATIC MOIST HEAT PACK ELECTRIC MOIST HEAT PACK IRT BATTLE CREEK EQUIPMENT COMPANY 155

    Patients

    Seq Age Sex Outcome Treatment
    1