BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GE AISYS CS2 ANESTHESIA MACHINES

    MDR report key: 24708573 · Received March 27, 2026

    Report

    Report Number
    MW5186018
    Event Type
    Injury
    Date Received
    March 27, 2026
    Date of Event
    October 17, 2025
    Report Date
    March 25, 2026
    Manufacturer
    DATEX-OHMEDA, INC./GE HEALTHCARE TECHNOLOGIES INC.
    Product Code
    BSZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    THE ANESTHESIA MACHINES GE AISYS CS2 THAT WERE PURCHASED AT (B)(6) AND INSTALLED HAVING DAILY PROBLEMS WITH NEAR MISSES WEEKLY. WITHOUT THE VIGILANT MONITORING BY ANESTHESIOLOGISTS AND NURSE ANESTHETISTS I AM CONCERNED WOULD HAVE PERMANENT NEGATIVE OUTCOMES. EXAMPLE OF FEW PROBLEMS, BREAKDOWNS OCCURRED DAY ONE. THE DAILY STRESS AND CONCERNS FOR PATIENT SAFETY AND WELL BEING IS HIGH. POTENTIAL MISCONNECTION OF THE BREATHING CIRCUIT (E.G., ACGO CONFIGURATION), WHICH MAY RESULT IN FAILURE TO DELIVER ADEQUATE VENTILATION OR ANESTHETIC GASES INACCURATE OR MISLEADING GAS PRESSURE DISPLAY (OXYGEN VS. AIR), CREATING A RISK OF UNRECOGNIZED OXYGEN DEPLETION AND HYPOXIA FLOW SENSOR RELIABILITY CONCERNS, WHICH MAY LEAD TO INACCURATE VENTILATION MEASUREMENTS AND DELAYED RECOGNITION OF HYPOVENTILATION. ALL PASSED AND MACHINES STILL BREAKING DOWN SAME DAY. ALL 20 OF OUR NEW MACHINES ALL SUFFERING THE SAME ISSUES. PT CODES: 1916, 1918, 2329. DEVICE CODES: 3005, 1089, 1266, 1383, 1399, 2917. REFERENCE REPORTS: MW5186014, MW5186015, MW5186016, MW5186017, MW5186019, MW5186020, MW5186021, MW5186022, MW5186023, MW5186024, MW5186025, MW5186026, MW5186027, MW5186028, MW5186029, MW5186030, MW5186031, MW5186032, MW5186033.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    769497 GE AISYS CS2 ANESTHESIA MACHINES GAS-MACHINE, ANESTHESIA BSZ DATEX-OHMEDA, INC./GE HEALTHCARE TECHNOLOGIES INC. AISYS CS2

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening| O| R