BEUDAMED
    FDA Adverse Event Death Summary report: N

    ANESTHESIA CART

    MDR report key: 18445117 · Received January 3, 2024

    Report

    Report Number
    MW5149764
    Event Type
    Death
    Date Received
    January 3, 2024
    Date of Event
    December 23, 2023
    Report Date
    December 29, 2023
    Manufacturer
    GE HEALTHCARE TECHNOLOGIES, INC. / DATEX-OHMEDA, INC.
    Product Code
    BSZ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ANESTHESIOLOGIST HAD TROUBLE WITH HIGH PEEP(POSITIVE END-EXPIRATORY PRESSURE) THROUGHOUT PROCEDURE AND HAD TO BAG PATIENT INTERMITTENTLY. ALTHOUGH OXYGEN SATURATION REMAINED AT 100% THROUGHOUT PROCEDURE, THE PATIENT DID NOT WAKE UP. CT(COMPUTED TOMOGRAPHY) RESULTS A FEW HOURS AFTER PROCEDURE SHOWED ANOXIC BRAIN INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1507339 ANESTHESIA CART GAS-MACHINE, ANESTHESIA BSZ GE HEALTHCARE TECHNOLOGIES, INC. / DATEX-OHMEDA, INC. AISYS CS2

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Female Death