BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOPHORE

    MDR report key: 64880 · Received January 23, 1997

    Report

    Report Number
    1811605-1997-90020
    Event Type
    Malfunction
    Date Received
    January 23, 1997
    Report Date
    January 10, 1997
    Manufacturer
    BATTLE CREEK EQUIPMENT CO.
    Product Code
    IRT
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    THE SWITCH EMITTED SMOKE. CO'S INSPECTION REVEALED CARBON DEPOSITS WERE PRESENT IN THE SWITCH. NO DEATHS OR INJURIES WERE REPORTED. FROM APPROX. 1967 TO JUNE 21,1990, CO USED A LISTED SWITCH MANUFACTURED BY A REPUTABLE FIRM. THE SWITCH WAS A MOMENTARY TYPE SWITCH WITH A SPRING LOADED LEVER WHICH REQUIRED BEING HELD IN THE "ON" POSITION TO MAKE CONTACT. SOMETIMES A USER WOULD NOT FULLY ENGAGE THE LEVER, ALLOWING THE CONTACTS TO REMAIN SLIGHTLY OPEN WHICH COULD INDUCE ARCING. WHEN CONSISTENTLY HELD IN THIS WAY, CARBON BUILD-UP FROM THE ARCING COULD REACH OPPOSITE POLES CAUSING THE SWITCH TO EMIT A SMALL AMOUNT OF SMOKE. CO'S FIRST SOLUTION WAS TO CHANGE THE CONTACT MATERIAL AND THE BODY OF THE SWITCH. THIS REDUCED THE ARCING OF THE CONTACTS AND THE CARBON TRACKING OF THE SWITCH BODY. ALTHOUGH THE SITUATION WAS IMPROVED, THE OCCASIONAL RELEASE OF A PUFF OF SMOKE WAS POSSIBLE. ON JUNE 21, 1990, CO BEGAN USING A SNAP ACTION SWITCH WHICH DOES NOT ALLOW THE CONTACTS TO BE HELD IN A SLIGHTLY OPEN POSITION. THIS REPORT IS BEING MADE TO BE COMPLIANT WITH REGULATORY LETTER 90-DT-12. REMEDIAL ACTION HAS BEN ACCOMPLISHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERMOPHORE HEATING PAD IRT BATTLE CREEK EQUIPMENT CO. 055 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 *