BEUDAMED
    FDA Adverse Event Other Summary report: N

    G.E./DATEX OHMEDA

    MDR report key: 978275 · Received January 9, 2008

    Report

    Report Number
    MW5004923
    Event Type
    Other
    Date Received
    January 9, 2008
    Date of Event
    December 5, 2007
    Report Date
    December 20, 2007
    Manufacturer
    G.E. REPAIR SVC CENTER
    Product Code
    BSZ
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHILE BEING USED ON A PATIENT, EQUIPMENT EMANATED BURNING SMELL, BLACK SMOKE & BLACK PARTICLES. NO FLAMES WERE OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 G.E./DATEX OHMEDA CARDIO CAP 5 BSZ G.E. REPAIR SVC CENTER

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR