BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BAIR HUGGER

    MDR report key: 1841655 · Received September 11, 2010

    Report

    Report Number
    1841655
    Event Type
    Malfunction
    Date Received
    September 11, 2010
    Date of Event
    July 22, 2010
    Report Date
    September 11, 2010
    Manufacturer
    ARIZANT HEALTHCARE INC.
    Product Code
    DWJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    BAIR HUGGER IN OR SUITE WAS PLUGGED INTO WALL OUTLET. STAFF WALKED IN AND SMELLED AN "ELECTRICAL BURNING SMELL" AND NOTED THE PLUG WAS BLACKENED. SCORTCH MARKS WERE NOTED ON THE BACK OF THE UNIT AND THE HOSE.====================== HEALTH PROFESSIONAL'S IMPRESSION======================THE HOT SPOT WAS FOUND ON THE WARMER NEAR WHERE THE POWER CORD PLUGS IN, THE CONTACTS WERE NOT BURNED. THE POWER CORD WAS NOT BURNED AND WAS INTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BAIR HUGGER SYSTEM, THERMAL REGULATING DWJ ARIZANT HEALTHCARE INC. MODEL 505 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *