BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WARMTOUCH COMPACT WARMING UNIT

    MDR report key: 2264177 · Received September 2, 2011

    Report

    Report Number
    2936999-2011-00556
    Event Type
    Malfunction
    Date Received
    September 2, 2011
    Date of Event
    August 5, 2011
    Report Date
    August 5, 2011
    Manufacturer
    COVIDIEN, FORMERLY TYCOHEALTHCARE
    Product Code
    DWJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE WT-5900 WARMTOUCH IS NOT DISTRIBUTED IN THE U.S.; HOWEVER, THE WT-5900 WARMTOUCH IS OF ESSENTIALLY IDENTICAL DESIGN AND IS DISTRIBUTED IN THE U.S. THE 510K NUMBER FOR THE WT-5900 WARMTOUCH IS K020604. THE REPORTED CUSTOMER COMPLAINT IS CONFIRMED. THE TEMPERATURE CONTROL WAS FOUND TO BE DEFECTIVE AND THE FAULT ISOLATED TO A DEFECTIVE CIRCUIT BOARD. ADDITIONALLY, THE FILTER COVER WAS REPLACED. REPLACED FILTER COVER AND DEFECTIVE CIRCUIT BOARD. PARTS REPLACED AND UNIT PASSED ALL FUNCTIONAL TESTING. INFORMATION HAS BEEN ADDED TO THE DATABASE FOR TRENDING PURPOSES.

    Description of Event or Problem · 1

    THE COMPANY RECEIVED A REPORT WHERE IT WAS CLAIMED THAT THE FILTER COVER MELTED DUE TO THE UNIT BEING HOT. THE CALLER COULD NOT RECALL THE TEMPERATURE OF THE DEVICE. UNIT IN USE WITH A PATIENT, THERE WAS NO PATIENT HARM REPORTED.

    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