BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOPHORE AUTOMATIC MOIST HEAT PACK

    MDR report key: 3221601 · Received July 1, 2013

    Report

    Report Number
    1811605-2013-00085
    Event Type
    Malfunction
    Date Received
    July 1, 2013
    Date of Event
    May 21, 2013
    Report Date
    June 11, 2013
    Manufacturer
    BATTLE CREEK EQUIPMENT COMPANY
    Product Code
    IRT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, 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 STAYS ON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297403 THERMOPHORE AUTOMATIC MOIST HEAT PACK ELECTRIC MOIST HEAT PACK IRT BATTLE CREEK EQUIPMENT COMPANY 155

    Patients

    Seq Age Sex Outcome Treatment
    1