BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WARMTOUCH COMPACT WARMING UNIT

    MDR report key: 2142066 · Received May 25, 2011

    Report

    Report Number
    2936999-2011-00350
    Event Type
    Malfunction
    Date Received
    May 25, 2011
    Date of Event
    April 28, 2011
    Report Date
    April 28, 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

    THE EVAL FOUND THE TEMPERATURE CONTROL OUT OF ORDER, THE ELECTRONIC PCB AND THERMISTOR WERE BROKEN. THE KEYPAD WAS WORN OUT. 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 BY COVIDIEN TECHNICIAN THAT THE WARMTOUCH TEMPERATURE WAS TOO HIGH. THE UNIT WOULD SHORT HEAT TO 53 DEGREESC IN ALL HEATING LEVELS. THE UNIT DID NOT SHUT DOWN OR GIVE AN ALARM. 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