BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WARMTOUCH COMPACT WARMING UNIT

    MDR report key: 1759603 · Received July 13, 2010

    Report

    Report Number
    2936999-2010-01021
    Event Type
    Malfunction
    Date Received
    July 13, 2010
    Date of Event
    May 27, 2010
    Report Date
    June 16, 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

    THE UNIT WAS RETURNED TO THE COVIDIEN SERVICE DEPARTMENT IN THE UNITED KINGDOM FOR DIAGNOSIS AND PERFORMANCE VERIFICATION TESTING (PVT). ALL ELECTRICAL SAFETY TESTS WERE PERFORMED TO THE TEST INSTRUCTION SPECIFICATIONS. THE UNIT PERFORMED AS INTENDED AND TEMPERATURE RANGE WAS WITHIN SPECIFICATION. THE FAILURE WAS NOT CONFIRMED. THE POWER CORD WAS FOUND TO BE BROKEN OR IN POOR CONDITION AND WAS REPLACED PER SERVICING. THERE WAS NO TEST DATA PROVIDED BY THE HOSPITAL ENGINEERS TO CONFIRM ANY DIAGNOSTIC TESTING WAS PERFORMED IN SUPPORT OF THEIR CONCLUSIONS REGARDING THE CAUSE OF THE REPORTED FAILURE. NOTE: THE WARMTOUCH (B)(4) IS NOT DISTRIBUTED IN THE U.S. HOWEVER, THE WARMTOUCH 5300 IS OF ESSENTIALLY IDENTICAL DESIGN AND IS DISTRIBUTED IN THE U.S. THE 510K NUMBER FOR THE WARMTOUCH 5300 IS K020604.

    Description of Event or Problem · 1

    THE LOCAL HOSPITAL TECHNICAL ENGINEERS REPORTED TO COVIDIEN SERVICE DEPARTMENT ENGINEERS THE ALARM ON THE WARMTOUCH DID NOT COME ON, THE TEMPERATURE WAS ABOVE SPECIFICATION AND IT DID NOT PERFORM THE STEP DOWN TO THE LOWER TEMPERATURE, THEY REPORTED THE CAUSE AS EITHER THE MAIN PCB, THERMISTOR SENSOR, OR BOTH. THERE WAS NO INFORMATION PROVIDED FROM THE TECHNICAL ENGINEERS TO SUGGEST THE EVENT OCCURRED DURING ANY PATIENT USE.

    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