BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOPHORE

    MDR report key: 8904852 · Received August 19, 2019

    Report

    Report Number
    1832415-2019-10677
    Event Type
    Malfunction
    Date Received
    August 19, 2019
    Report Date
    July 30, 2019
    Manufacturer
    BATTLE CREEK EQUIPMENT
    Product Code
    IRT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER STATED, "PAD WAS LAYING ON THE BED WHEN IT STARTED A FIRE." THE PRODUCT WAS RETURNED FOR INVESTIGATION. THE CUSTOMER DID NOT CLAIM ANY INJURY. THE PRODUCT WAS APPROX. 19 YEARS OLD WHEN THE INCIDENT OCCURRED. AN INVESTIGATION WAS DONE TO LOOK INTO THE CUSTOMERS COMPLAINT. INVESTIGATOR DETERMINED THE CUSTOMER WAS LAYING ON THE PAD DURING USE. THE LAYING ON THE PAD LED TO THE PVC TUBING ON THE HARNESS TO WEAKEN AND THE STAT INSIDE TO WEAKEN. THIS IS LIKELY THE CAUSE OF THE BURN THE CUSTOMER DESCRIBED. THE ALSO CUSTOMER ADMITTED TO LAYING ON THE UNIT. THE FAILURE THE CUSTOMER HAD WAS DUE TO THE CUSTOMER MISUSING THE PRODUCT. IFU STATES, "DO NOT SIT ON, LIE ON, OR CRUSH PAD. AVOID SHARP FOLDS".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    698624 THERMOPHORE THERMOPHORE IRT BATTLE CREEK EQUIPMENT 155 008093

    Patients

    Seq Age Sex Outcome Treatment
    1