BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WARM TOUCH II COMPACT WARMING UNIT

    MDR report key: 1860365 · Received September 24, 2010

    Report

    Report Number
    2936999-2010-01215
    Event Type
    Malfunction
    Date Received
    September 24, 2010
    Date of Event
    August 1, 2010
    Report Date
    August 27, 2010
    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 COVIDIEN SERVICE TECH PERFORMED INSPECTION AND PERFORMANCE TESTING AND FOUND THE TURBINE (FAN) WAS MISSING FROM THE UNIT, HOWEVER, THERE WAS NO EVIDENCE OF SMOKE OR ANY BURNED HOUSING OR COMPONENTS. IT COULD NOT BE CONFIRMED WHEN OR BY WHOM THE TURBINE WAS REMOVED. PART # 501-5800 IS NOT DISTRIBUTED IN THE U.S; HOWEVER THERE IS A DEVICE OF ESSENTIALLY IDENTICAL DESIGN DISTRIBUTED IN THE UNITED STATES. APPLICABLE 510K# FOR US DISTRIBUTED PART IS K913016.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED "THE UNIT WAS VERY NOISY AND SMELLS LIKE BURNED". NO PT INVOLVEMENT WAS REPORTED. THE COVIDIEN SERVICE TECH CALLED AND SPOKE TO THE CUSTOMER'S SERVICE TECH WHO STATED THE BLOWER WAS DEFECTIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WARM TOUCH II COMPACT WARMING UNIT CONVECTIVE AIR WARMER DWJ COVIDIEN, FORMERLY TYCO HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1