BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOPHORE AUTOMATIC MOIST HEAT PACK

    MDR report key: 2904568 · Received December 5, 2012

    Report

    Report Number
    1811605-2012-00158
    Event Type
    Malfunction
    Date Received
    December 5, 2012
    Date of Event
    October 1, 2012
    Report Date
    December 4, 2012
    Manufacturer
    BATTLE CREEK EQUIPMENT COMPANY
    Product Code
    IRT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE SWITCH COMPONENTS REVEALED THAT SENSITIVITY TO EXTERNAL STRESS HAD CAUSED THE FAILURE OF A RESISTOR. THE FAILURE RESULTED IN A SMALL SPARK THAT WAS CONTAINED BY OUR DOUBLE-INSULATED DESIGN. ALTHOUGH THIS IS NOT A STATISTICALLY SIGNIFICANT COMPLAINT AND MAY BE DUE TO MISUSE OR FAILURE TO FOLLOW INSTRUCTIONS OF THE PART OF THE CONSUMER, WE HAVE INITIATED THE FOLLOWING CORRECTIVE ACTIONS: WE HAVE REINFORCED THE TERMINALS LEADING INTO THE SWITCH TO REDUCE THE POSSIBILITY OF CURRENT FLUCTUATIONS AND/OR OPEN CONTINUITY. WE HAVE REPOSITIONED COMPONENTS TO REDUCE THE POSSIBILITY OF ACCIDENTAL CONTACT BETWEEN LIVE COMPONENTS.

    Description of Event or Problem · 1

    THE USER REPORTED THAT THE UNIT CAUSED 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 095

    Patients

    Seq Age Sex Outcome Treatment
    1