BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOPHORE AUTOMATIC MOIST HEAT PACK

    MDR report key: 1791171 · Received July 30, 2010

    Report

    Report Number
    1811605-2010-00281
    Event Type
    Malfunction
    Date Received
    July 30, 2010
    Date of Event
    January 1, 2010
    Report Date
    July 20, 2010
    Manufacturer
    BATTLE CREEK EQUIPMENT COMPANY
    Product Code
    IRT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THE ELECTRICAL CORD EMITTED A SPARK. EXAMINATION OF THE CORD REVEALED A BREAK AT THE ENTRANCE TO THE STRAIN RELIEF AREA NEAR THE SWITCH. ALTHOUGH THIS IS NOT A STATISTICALLY SIGNIFICANT COMPLAINT AND MAY BE DUE TO MISUSE OR FAILURE TO FOLLOW INSTRUCTIONS ON THE PART OF THE CONSUMER, WE HAVE INITIATED THE FOLLOWING CORRECTIVE ACTIONS: AFTER CONSULTATION WITH OUR VENDOR REGARDING THIS ISSUE, WE RE-DESIGNED OUR ELECTRIC CORD AND STRAIN RELIEF IN AN EFFORT TO REDUCE THE STRESS AT THE POINT WHERE THE FLEXIBLE CORD ENTERS THE RIGID SWITCH HOUSING. ADDITIONAL REMEDIAL ACTION INCLUDED THE CONVERSION TO A PREVIOUS VENDOR WHO HAS HISTORICALLY BEEN ABLE TO PRODUCE A CORD-SET PROVIDING EVEN MORE DURABILITY. WE WILL MONITOR THIS ISSUE IN A CONTINUING EFFORT TO REDUCE SIMILAR COMPLAINTS IN THE FUTURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE ELECTRICAL CORD EMITTED A SPARK.

    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