BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AISYS CS2 ¿ GE HEALTHCARE

    MDR report key: 24941569 · Received April 21, 2026

    Report

    Report Number
    MW5187050
    Event Type
    Malfunction
    Date Received
    April 21, 2026
    Date of Event
    November 20, 2025
    Report Date
    April 16, 2026
    Manufacturer
    GE MEDICAL SYSTEMS (CHINA) CO., LTD.
    Product Code
    BSZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DURING A SIMPLE BAL PROCEDURE, ANESTHESIA NOTICED THAT IT APPEARED THAT THE PATIENT WAS NOT BEING VENTILATED. THE PATIENT VITALS WERE CHANGING. THE PATIENT HAD AN LMA INITIALLY AND HE INTUBATED THE PATIENT AND BEGAN TO US THE BVM TO VENTILATE THE PATIENT. A CODE BLUE WAS CALLED, ONCE PULSES RETURNED, PATIENT WAS PLACED ON A RESPIRATORY TRANSPORT VENTILATOR AND TRANSFERRED TO ICU. IT WAS DETERMINED BY THE ANESTHESIA TECH THAT THE BELLOWS ON THE ANESTHESIA VENT WAS NOT WORKING. BIO MED LATER CAME AND THAT PART OF THE VENT WAS CHANGED AND WAS CHECKED. I REQUESTED THE ANESTHESIA VENTILATOR BE PULLED FROM SERVICE TODAY (B)(6). EVENT TOOK PLACE (B)(6) 2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    276643 AISYS CS2 ¿ GE HEALTHCARE GAS-MACHINE, ANESTHESIA BSZ GE MEDICAL SYSTEMS (CHINA) CO., LTD. AISYS CS2

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female