BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRAGER/AIR SHIELDS

    MDR report key: 1022277 · Received March 28, 2008

    Report

    Report Number
    MW5006088
    Event Type
    Malfunction
    Date Received
    March 28, 2008
    Date of Event
    March 2, 2008
    Report Date
    March 28, 2008
    Product Code
    FMT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    BABY PLACED IN INFANT WARMER WHEN AT THAT TIME AN "ELECTRICAL BURNING SMELL" WAS NOTED BY PARENT AND STAFF. THE INFANT AND THE MOTHER WERE REMOVED FROM WARMER AND ROOM. NOTED: A FIRE ALARM WENT OFF THE NIGHT BEFORE FROM THE SAME ROOM. IT WAS UNDETERMINED WHY THE ALARM WAS SET OFF - THE FIRE DEPARTMENT DID END UP COMING TO THE FLOOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DRAGER/AIR SHIELDS INFANT WARMER FMT PM78-1

    Patients

    Seq Age Sex Outcome Treatment
    1