BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOPHORE AUTOMATIC MOIST HEAT PACK

    MDR report key: 2241538 · Received August 30, 2011

    Report

    Report Number
    1811605-2011-00105
    Event Type
    Malfunction
    Date Received
    August 30, 2011
    Date of Event
    August 1, 2011
    Report Date
    August 23, 2011
    Manufacturer
    BATTLE CREEK EQUIPMENT CO
    Product Code
    IRT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THE UNIT STOPPED WORKING, AND IT WAS RETURNED TO US UNDER WARRANTY. EXAMINATION OF THE UNIT REVEALED A BREAK IN THE CORD AT THE ENTRANCE TO THE STRAIN RELIEF AREA NEAR THE SWITCH. THE BREAK PREVENTS THE WIRES IN THE CORD FROM MAKING CONTINUOUS CONTACT AND COULD POSSIBLY EXPOSE BARE WIRES WHEN THE CORD IS BENT. WE ALSO OBSERVED THAT THE CORD OF THE UNIT WAS SEVERELY TWISTED, WHICH SUGGESTS IT WAS BEING USED IN AN UNUSUAL MANNER. THE FAILURE MAY BE A RESULT OF MISUSE OR FAILURE TO FOLLOW INSTRUCTIONS ON THE PART OF THE CONSUMER BY SUBJECTING THE CORD TO EXCESSIVE STRESS. ALTHOUGH USERS ARE INSTRUCTED NOT TO BEND OR TWIST THE CORD, WE ARE TAKING APPROPRIATE ACTION TO MAKE THE DESIGN MORE ROBUST BY INITIATING A CAPA PROJECT ((B)(4)) TO PREVENT THIS FAILURE FROM RECURRING.

    Description of Event or Problem · 1

    IT WAS REPORTED THE UNIT STOPPED WORKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERMOPHORE AUTOMATIC MOIST HEAT PACK ELECTRIC MOIST HEAT PACK IRT BATTLE CREEK EQUIPMENT CO 055

    Patients

    Seq Age Sex Outcome Treatment
    1