BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WARMTOUCH COMPACT WARMING UNIT

    MDR report key: 1993882 · Received January 12, 2011

    Report

    Report Number
    2936999-2011-00024
    Event Type
    Malfunction
    Date Received
    January 12, 2011
    Date of Event
    December 14, 2010
    Report Date
    December 14, 2010
    Manufacturer
    COVIDIEN/FORMERLY TYCO HEALTHCARE
    Product Code
    DWJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE UNIT NEEDED A NEW CONTROL PANEL. THE DAMAGED FRONT COVER WAS REPLACED, ALONG WITH THE FILTER, COVER, HOSE AND NOZZLE. THE WT-5900 WARMTOUCH IS NOT DISTRIBUTED IN THE U.S.; HOWEVER, THE WT-5900 WARMTOUCH IS OF ESSENTIALLY IDENTICAL DESIGN AND IS DISTRIBUTED IN THE U.S. THE 510K NUMBER FOR THE WT-5900 WARMTOUCH IS K020604.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN THAT WARMTOUCH BLOWER 5900 WAS REPORTED TO HAVE HOT/SMOKING/ODOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WARMTOUCH COMPACT WARMING UNIT CONVECTIVE AIR WARMER DWJ COVIDIEN/FORMERLY TYCO HEALTHCARE WT-5900

    Patients

    Seq Age Sex Outcome Treatment
    1