BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WARM TOUCH BLOWER MODEL 5800

    MDR report key: 1230866 · Received November 6, 2008

    Report

    Report Number
    2936999-2008-00558
    Event Type
    Malfunction
    Date Received
    November 6, 2008
    Date of Event
    September 1, 2008
    Report Date
    October 14, 2008
    Manufacturer
    COVIDIEN, FORMERLY TYCO HEALTHCARE
    Product Code
    DWJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE UNIT WAS EVALUATED AND THE BLOWER WAS FOUND TO BE DEFECTIVE; THE INSULATING RESISTANCE WAS LOW. THE CUSTOMER'S REPORTED FAILURE WAS CONFIRMED. THE BLOWER WAS REPLACED. THE DAMAGED KEYPAD WAS REPLACED. ALL FUNCTIONS PERFORMED AND PASSED BY THE ASSOCIATION OF FOREIGN ELECTRICIANS.

    Description of Event or Problem · 1

    CUSTOMER COMPLAINED OF ELECTRICAL SMELL AND INSULATION FAILURE. THE "OP" PERSON SWITCHED THE UNIT ON AND THEN THEY NOTED THE CABLE SMELL. THEY THEN TURNED THE UNIT OFF. THE UNIT WAS RUNNING TWO MINUTES AND, THEREFORE, THE CUSTOMER WAS UNABLE TO DETERMINE IF THE UNIT WOULD HAVE PERFORMED THE STEP-DOWN TO GO TO A LOWER TEMPERATURE OR TURN OFF ON IT'S OWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WARM TOUCH BLOWER MODEL 5800 CONVECTIVE AIR WARMER DWJ COVIDIEN, FORMERLY TYCO HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1