BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WARMTOUCH COMPACT WARMING UNIT

    MDR report key: 1774360 · Received July 14, 2010

    Report

    Report Number
    2936999-2010-01025
    Event Type
    Malfunction
    Date Received
    July 14, 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 DEPT IN THE (B)(4) FOR DIAGNOSIS AND PERFORMANCE VERIFICATION TESTING (PVT). ALL ELECTRICAL SAFETY TESTS WERE PERFORMED TO THE TEST INSTRUCTION SPECIFICATIONS. THE UNIT PERFORMED AS INTENDED AND TEMP RANGE WAS WITHIN SPECIFICATION. THE FAILURE WAS NOT CONFIRMED. THE TEMP SENSOR WAS RE-FITTED AND THE HEPA-FILTER WAS REPLACED PER SERVICING. THERE WAS NO TEST DATA PROVIDED BY THE HOSP ENGINEERS TO CONFIRM ANY DIAGNOSTIC TESTING WAS PERFORMED IN SUPPORT OF THEIR CONCLUSIONS REGARDING THE CAUSE OF THE REPORTED FAILURE. NOTE: THE WARMTOUCH 5800 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 # FOR THE WARMTOUCH 5300 IS K020604.

    Description of Event or Problem · 1

    THE LOCAL HOSP TECH ENGINEERS REPORTED TO COVIDIEN SERVICE DEPT ENGINEERS THE ALARM ON THE WARMTOUCH DID NOT COME ON, THE TEMP WAS ABOVE SPECIFICATION AND IT DID NOT PERFORM THE STEP DOWN TO THE LOWER TEMP. THEY REPORTED THE CAUSE AS EITHER THE MAIN PCB, THERMISTOR SENSOR, OR BOTH. THERE WAS NO INFO PROVIDED FROM THE TECH ENGINEERS TO SUGGEST THE EVENT OCCURRED DURING ANY PT 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