BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WARM TOUCH COMPACT WARMING UNIT

    MDR report key: 1172173 · Received September 17, 2008

    Report

    Report Number
    2936999-2008-00445
    Event Type
    Malfunction
    Date Received
    September 17, 2008
    Date of Event
    August 1, 2008
    Report Date
    August 25, 2008
    Manufacturer
    COVIDIEN/FORMERLY TYCO
    Product Code
    DWJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    COVIDIEN HAS REQUESTED THAT THE UNIT BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN THAT IN PREPARATION FOR A PATIENT, THE USERS NOTICED A BURNING SMELL BEFORE APPLYING TO THE PT. THERE WAS NO PATIENT INVOLVEMENT. THE UNIT WAS BROUGHT TO BIOMED AND BIOMED HAD TO SHUT IT OFF MANUALLY. IT IS UNK HOW LONG THE UNIT WAS ON BEFORE IT BEGAN TO SMOKE AND UNK WHAT SETTING IT WAS ON IN THE O.R.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1