BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WARMTOUCH COMPACT WARMING UNIT

    MDR report key: 1961559 · Received December 23, 2010

    Report

    Report Number
    2936999-2010-01404
    Event Type
    Malfunction
    Date Received
    December 23, 2010
    Date of Event
    November 25, 2010
    Report Date
    November 25, 2010
    Manufacturer
    COVIDIEN/FORMERLY TYCO
    Product Code
    DWJ
    PMA / PMN Number
    K913016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE WARMTOUCH 5900 IS NOT DISTRIBUTED IN THE U.S.; HOWEVER, THE 5300A WARMTOUCH IS OF ESSENTIALLY IDENTICAL DESIGN AND IS DISTRIBUTED IN THE U.S. THE 510K NUMBER FOR THE 5300A WARMTOUCH IS K913016.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN THAT HOSPITAL ENGINEERS CHECKED THE UNIT AND FOUND THAT IT WAS OVERHEATING. IT WAS REPORTED THAT NO PT WAS INVOLVED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1