BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOPHORE AUTOMATIC HEAT PACK

    MDR report key: 3883847 · Received June 13, 2014

    Report

    Report Number
    1811605-2014-00133
    Event Type
    Malfunction
    Date Received
    June 13, 2014
    Date of Event
    May 15, 2014
    Report Date
    June 13, 2014
    Manufacturer
    BATTLE CREEK EQUIPMENT
    Product Code
    IRT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    OUR EXAMINATION REVEALED THAT ONE OF THE TERMINALS HAD BEEN BROKEN NEAR A THERMOSTAT, WHICH HAD COMPROMISED OUR DOUBLE-INSULATED DESIGN. 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 ATTRIBUTED TO MISUSE BY THE USER, AND FAILURE TO FOLLOW INSTRUCTIONS AS TO THE CARE AND HANDLING OF THE UNIT. ALTHOUGH WARNING LABELS AND INSTRUCTION BOOKLETS WARN AGAINST SITTING OR LAYING ON THE PRODUCT, WE HAVE A CORRECTIVE ACTION PROJECT (B)(4) UNDERWAY TO MAKE THE DESIGN MORE ROBUST.

    Description of Event or Problem · 1

    WHILE SPEAKING WITH OUR C.S., THE CUSTOMER PLUGGED THE PAD IN AND IT CAUGHT FIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351377 THERMOPHORE AUTOMATIC HEAT PACK ELECTRIC MOIST HEAT PACK IRT BATTLE CREEK EQUIPMENT 155

    Patients

    Seq Age Sex Outcome Treatment
    1