BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOPHORE AUTOMATIC MOIST HEAT PACK

    MDR report key: 2022453 · Received February 15, 2011

    Report

    Report Number
    1811605-2011-00010
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    January 1, 2011
    Report Date
    August 16, 2010
    Manufacturer
    BATTLE CREEK EQUIPMENT CO.
    Product Code
    IRT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED, THE FABRIC FOUNDATION OF THE UNIT WAS BURNED BY AN INTERNAL COMPONENT. OUR EXAM REVEALED THAT ONE OF THE TERMINALS HAD BEEN BROKEN NEAR A THERMOSTAT, RESULTING IN A SPARK WHICH HAD COMPROMISED OUR DOUBLE-INSULATED DESIGN, CAUSING A 1/4" DIAMETER HOLE IN THE FABRIC FOUNDATION. WE ALSO FOUND SEVERAL OTHER INTERNAL COMPONENTS THAT WERE DAMAGED, INDICATING THAT THE CUSTOMER MISUSED THE PAD BY APPLYING AN EXCESSIVE, LOCALIZED FORCE ON OR NEAR THE THERMOSTAT TERMINAL. WE CONCLUDED THAT THIS REPORT WAS ATTRIBUTABLE TO MISUSE BY THE USER, AND FAILURE TO FOLLOW INSTRUCTIONS AS TO THE CARE AND HANDLING OF THE UNIT.

    Description of Event or Problem · 1

    IT WAS REPORTED, THE FABRIC FOUNDATION OF THE UNIT WAS BURNED BY AN INTERNAL COMPONENT.

    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