BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GE DATEX-OHMEDA

    MDR report key: 4475930 · Received January 28, 2015

    Report

    Report Number
    MW5040520
    Event Type
    Malfunction
    Date Received
    January 28, 2015
    Date of Event
    January 21, 2015
    Report Date
    January 21, 2015
    Manufacturer
    DATEX-OHMEDA
    Product Code
    MHX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ANESTHESIA MONITOR ELECTRICAL MALFUNCTION AND MAIN BOARD PRODUCED BLACK SMOKE. FIRE ALARM ACTIVATED PATIENT REMOVED FROM ROOM IMMEDIATELY TRANSPORTED TO PH I.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66020 GE DATEX-OHMEDA ANESTHESIA MONITOR MHX DATEX-OHMEDA 6051-0000-164

    Patients

    Seq Age Sex Outcome Treatment
    1