BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GE HEALTHCARE AISYS CS2 ANESTHESIA MACHINE

    MDR report key: 10128322 · Received June 5, 2020

    Report

    Report Number
    MW5094874
    Event Type
    Injury
    Date Received
    June 5, 2020
    Date of Event
    May 24, 2020
    Report Date
    June 4, 2020
    Manufacturer
    GE HEALTHCARE/ DATEX-OHMEDA, INC.
    Product Code
    BSZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ANESTHESIOLOGIST WAS NOT AWARE CARTRIDGE EJECTED CAUSING INADEQUATE FLOW OF ANESTHESIA, SO PATIENT HAD SOME AWARENESS PRIOR TO ISSUE BEING DISCOVERED. THIS IS NEWER ANESTHESIA MACHINE AND MACHINE DOES NOT PROVIDE ALARM OR FLASHING LIGHTS OR ANYTHING TO ALERT THAT CARTRIDGE NOT SECURELY LOCKED IN. SEEMS INSERTING CARTRIDGE REQUIRES MORE FORCE AND A DOUBLE CHECK TO ENSURE IT IS LOCKED IN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    588596 GE HEALTHCARE AISYS CS2 ANESTHESIA MACHINE GAS-MACHINE, ANESTHESIA BSZ GE HEALTHCARE/ DATEX-OHMEDA, INC. AISYS CS2 1011-9050-000

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Other