BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOPHORE AUTOMATIC HEAT PACK

    MDR report key: 3924783 · Received July 1, 2014

    Report

    Report Number
    1811605-2014-00154
    Event Type
    Malfunction
    Date Received
    July 1, 2014
    Date of Event
    June 5, 2014
    Report Date
    July 2, 2014
    Manufacturer
    BATTLE CREEK EQUIPMENT
    Product Code
    IRT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    OUR INSPECTION FOUND A SMALL CUT IN THE CORD NEAR THE SWITCH THAT COULD HAVE EXPOSED THE USER TO BARE WIRE. THE INSPECTION ALSO REVEALED CUSTOMER MISUSE AS OUR INSPECTION FOUND: FDA: CORD CUT/BURNED STRAIN RELIEF, SWITCH OK, PAD BUNCHED, BENT/BROKEN LEAD, BENT/BROKEN THERMOSTAT. THIS TELLS US THAT THE PAD WAS NOT BEING PROPERLY USED AS PER OUR INSTRUCTIONS IN THE MANUAL. CORD BREAKAGE USUALLY OCCURS WHEN THE CORD IS REPEATEDLY OVER BENT NEAR THE SWITCH. WE HAVE INITIATED A CAPA PROJECT (B)(4) TO REDUCE THE OCCURRENCE OF THIS ISSUE. A NEW JACKETED CORD DESIGN WAS LAUNCHED IN PRODUCTION ON (B)(4) 2014 THAT CLOSES (B)(4) PENDING A FUTURE EVALUATION OF THE EFFECTIVENESS OF THE SOLUTION.

    Description of Event or Problem · 1

    CUSTOMER STATED THE PAD CAUGHT FIRE BY THE SWITCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    381623 THERMOPHORE AUTOMATIC HEAT PACK ELECTRIC MOIST HEAT PACK IRT BATTLE CREEK EQUIPMENT 055

    Patients

    Seq Age Sex Outcome Treatment
    1