BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GE HEALTHCARE ANESTHESIA CART

    MDR report key: 16809498 · Received April 24, 2023

    Report

    Report Number
    MW5117000
    Event Type
    Malfunction
    Date Received
    April 24, 2023
    Date of Event
    April 18, 2023
    Report Date
    April 20, 2023
    Manufacturer
    GE HEALTHCARE FINLAND OY
    Product Code
    BSZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE ANESTHESIA CART SCREEN THAT DISPLAYS THE VENTILATOR SETTINGS WENT BLANK AND WOULD NOT TURN BACK ON AFTER TROUBLESHOOTING. A TRANSPORT VENTILATOR WAS BROUGHT TO THE ROOM AND THE PATIENT WAS SWITCHED FROM THE ANESTHESIA CART TO THE TRANSPORT VENT. CLINICAL ENGINEERING REPLACED FAULTY MONITOR. NO VISIBLE WEAR/TEAR OF MACHINE, NO ERROR CODE TO DESCRIBE WHY UNIT WAS FAULTY OR POWERED DOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1745633 GE HEALTHCARE ANESTHESIA CART GAS-MACHINE, ANESTHESIA BSZ GE HEALTHCARE FINLAND OY AISYS CS2

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other