BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WARM TOUCH COMPACT WARMING UNIT

    MDR report key: 1993683 · Received January 6, 2011

    Report

    Report Number
    2936999-2011-00010
    Event Type
    Malfunction
    Date Received
    January 6, 2011
    Date of Event
    October 20, 2010
    Report Date
    December 7, 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

    INVESTIGATION FOUND THE THERMISTOR WAS NOT IN THE CORRECT POSITION, PARTIALLY RETRACTED IN THE SUPPORT TUBE. THE THERMISTOR WAS REPOSITIONED AND TESTED. THE FRONT CASE WAS DAMAGED AND REPLACED. IT WAS UNK HOW THE THERMISTOR GOT OUT OF THE CORRECT POSITION. THE WT-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 K020604.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN THAT THE UNIT WAS ALARMING INTERMITTENTLY AFTER ONE HOUR USE WHILE IN USE WITH A PT. THE UNIT WAS REPLACED. THE PT WAS NOT INJURED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1