BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7810 VENTILATOR

    MDR report key: 1203669 · Received October 9, 2008

    Report

    Report Number
    2112667-2008-00042
    Event Type
    Malfunction
    Date Received
    October 9, 2008
    Date of Event
    September 12, 2008
    Report Date
    October 9, 2008
    Manufacturer
    DATEX-OHMEDA
    Product Code
    CBK
    PMA / PMN Number
    K910847
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    EXACT MONTH COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT APPROX 15 MINUTES AFTER UNIT WAS TURNED ON, SMOKE WAS NOTED TO SPEW FROM VENTILATOR HOUSING AND ROOM FILLED WITH SMOKE. THERE WAS NO REPORTED PT INVOLVEMENT. GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS STILL ONGOING. A F/U REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAS BEEN COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 7810 VENTILATOR ANESTHESIA VENTILATOR CBK DATEX-OHMEDA 1500-8000-000

    Patients

    Seq Age Sex Outcome Treatment
    1