BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WARMTOUCH COMPACT WARMING UNIT

    MDR report key: 2261737 · Received August 30, 2011

    Report

    Report Number
    2936999-2011-00548
    Event Type
    Malfunction
    Date Received
    August 30, 2011
    Date of Event
    August 1, 2011
    Report Date
    August 1, 2011
    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

    INVESTIGATION FOUND HEAT SETTINGS NOT WORKING, UNIT HEATS CONTINUOUSLY, PCB BOARD WAS DEFECTIVE AND REPLACED. THE MANUFACTURER DATE IS UNK. 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

    IT WAS REPORTED TO COVIDIEN THAT UNIT ALWAYS ON SAME TEMPERATURE. THE UNIT GAVE AN ALARM. THE UNIT ALWAYS HEAT ON THE SAME TEMPERATURE, NO STEP DOWN. UNIT IN USE WITH A PT, THERE WAS NO PT HARM REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1