BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOPHORE AUTOMATIC MOIST HEAT PACK

    MDR report key: 3072224 · Received September 10, 2012

    Report

    Report Number
    1811605-2012-00143
    Event Type
    Malfunction
    Date Received
    September 10, 2012
    Date of Event
    September 1, 2012
    Report Date
    September 4, 2012
    Manufacturer
    BATTLE CREEK EQUIPMENT COMPANY
    Product Code
    IRT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE SWITCH WOULD NOT TURN OFF. UPON, EXAMINATION, WE DISCOVERED THAT A RESISTOR SHORTED ON THE CIRCUIT BOARD. THE FLAME-RETARDANT SWITCH HOUSING CONTAINED THE EVENT PROPERLY. AT OUR REQUEST, THE MANUFACTURER OF THE SWITCH HAS ENACTED SEVERAL CAPA PROJECTS TO IMPROVE THE QUALITY OF THE SWITCH. THE OCCURRENCE OF BOARD COMPONENT FAILURE HAS DROPPED SIGNIFICANTLY IN THE PAST 12 MONTHS.

    Description of Event or Problem · 1

    IT WAS REPORTED THE SWITCH WOULD NOT TURN OFF.

    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 COMPANY 055

    Patients

    Seq Age Sex Outcome Treatment
    1