BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WARMTOUCH COMPACT WARMING UNIT

    MDR report key: 2245014 · Received July 29, 2011

    Report

    Report Number
    2936999-2011-00509
    Event Type
    Malfunction
    Date Received
    July 29, 2011
    Date of Event
    June 29, 2011
    Report Date
    June 29, 2011
    Manufacturer
    COVIDIEN/FORMERLY TYCO
    Product Code
    DWJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    COVIDIEN TECHNICIAN CONFIRMED CASE HAS MELTED IN AREA ABOVE HEATING ELEMENT (AIR INLET AREA). ON TESTING FOUND THAT BLOWER HAS FAILED, LEADING TO ELEMENT OVERHEATING. APPROXIMATE YEAR OF MANUFACTURE IS 1999. THE WT-5800 WARMTOUCH IS NOT DISTRIBUTED IN THE U.S.; HOWEVER, THE WT-5300 WARMTOUCH IS OF ESSENTIALLY IDENTICAL DESIGN AND IS DISTRIBUTED IN THE U.S. THE 510K NUMBER FOR THE WT-5300 WARMTOUCH IS K020604.

    Description of Event or Problem · 1

    WARMTOUCH WAS RETURNED FOR CHECK FOR PROPER OPERATION. EVALUATION CONFIRMED CASE HAS MELTED IN AREA ABOVE HEATING ELEMENT (AIR INLET AREA). ON TESTING FOUND THAT BLOWER HAS FAILED, LEADING TO ELEMENT OVERHEATING. NO PATIENT WAS INJURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WARMTOUCH COMPACT WARMING UNIT CONVECTIVE AIR WARMER DWJ COVIDIEN/FORMERLY TYCO

    Patients

    Seq Age Sex Outcome Treatment
    1