BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOPHORE ARTHRITIS PAD

    MDR report key: 2232975 · Received July 22, 2011

    Report

    Report Number
    1811605-2011-00083
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 30, 2011
    Manufacturer
    BATTLE CREEK EQUIPMENT COMPANY
    Product Code
    IRT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THE SWITCH EMITTED SPARKS. UPON EXAMINATION, WE DISCOVERED THAT THE SWITCH WAS NON-FUNCTIONAL WITH CONNECTING WIRES PULLED FROM THE CIRCUIT BOARD, CAUSING A COMPONENT TO SHORT AND EMIT A SPARK. THERE WAS ALSO EVIDENCE THAT THE PAD HAD BEEN FOLDED AND BUNCHED, WHICH IS CONTRARY TO OUR INSTRUCTIONS AND WARNINGS. AT OUR REQUEST, THE MANUFACTURER OF THE SWITCH HAS ENACTED SEVERAL CAPA PROJECTS TO IMPROVE THE DURABILITY OF THE SWITCH. THE CONDITION OF THE PAD SUGGESTS THAT THE PAD MIGHT HAVE BEEN CAUGHT IN SOMETHING WHICH APPLIED AN EXCESSIVE FORCE TO THE CORD.

    Description of Event or Problem · 1

    IT WAS REPORTED THE SWITCH EMITTED SPARKS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1