BEUDAMED
    FDA Adverse Event Other Summary report: N

    AESTIVA 3000

    MDR report key: 841855 · Received April 25, 2007

    Report

    Report Number
    MW1042672
    Event Type
    Other
    Date Received
    April 25, 2007
    Date of Event
    April 12, 2007
    Report Date
    April 18, 2007
    Manufacturer
    GE HEALTHCARE/DATEX-OHMEDA
    Product Code
    BSZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    ANESTHESIA MACHINE NITROUS OXIDE FLOWMETER MALFUNCTION. DISCOVERED LOOSE NITROUS OXIDE FLOWMETER KNOB. ATTEMPTED LINK 25 ADJUSTMENT AND COULDN'T REMOVE N2O LINK ASSEMBLY, THE VALVE STEM WAS GROOVED, ATTEMPTED LINK 25 WITH ASSEMBLY IN PLACE AND THE N2O FLOW MAXED AT 10L / MIN WITH NO FLOWMETER REGULATION POSSIBLE. SUSPECT LOOSE N2O VALVE STEM ASSEMBLY CAUSED VALVE SEAT TO WEAR, CAUSING A "FREE FLOW N2O SITUATION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AESTIVA 3000 ANESTHESIA MACHINE BSZ GE HEALTHCARE/DATEX-OHMEDA AESTIVA 3000 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other