BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRAGER/AIRSHIELDS

    MDR report key: 692233 · Received March 6, 2006

    Report

    Report Number
    MW1038213
    Event Type
    Malfunction
    Date Received
    March 6, 2006
    Date of Event
    November 10, 2005
    Report Date
    March 6, 2006
    Manufacturer
    *
    Product Code
    FMZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    STAFF PREPARING TO TRANSPORT INFANT TO ICN. ODOR NOTICED BY PHYSICIAN. SMOKE NOTED COMING FROM FRONT OF ISOLETTE. INFANT REMOVED WITHOUT HARM. BIOMED TOOK ISOLETTE FOR EVAL. FOUND JACK ON THE POWER CHASSIS ASSEMBLY HAD OVERHEATED AND MELTED. BIOMED REPLACED SUBASSEMBLY TO FIX THE UNIT. ALSO REPLACED SAME SUBASSEMBLY ON SECOND UNIT. INCIDENT MAY BE AGE RELATED SINCE ELECTRONICAL/ELECTRONIC COMPONENTS BREAK DOWN OVER TIME AND CAN MALFUNCTION. UNITS WERE PURCHASED IN 1981 AND 1991, RESPECTIVELY. SINCE MFR STILL SUPPORTS THIS UNIT, USE MAY CONTINUE REGARDLESS OF AGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DRAGER/AIRSHIELDS ISOLETTE FMZ * T1100-1 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other