BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WARMTOUCH COMPACT WARMING UNIT

    MDR report key: 2261738 · Received August 30, 2011

    Report

    Report Number
    2936999-2011-00546
    Event Type
    Malfunction
    Date Received
    August 30, 2011
    Date of Event
    July 28, 2011
    Report Date
    July 28, 2011
    Manufacturer
    COVIDIEN/FORMERLY TYCOHEALTHCARE
    Product Code
    DWJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    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. THE MANUFACTURER DATE IS UNK.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN THAT TEMPERATURE WAS TOO HIGH. UNIT WAS CHECKED AND FOUND THERE WAS NO TEMPERATURE CONTROL, THERMISTOR DEFECTIVE. KEYPAD IS WORN OUT. NO PT INVOLVED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1