BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GE HEALTHCARE AISYS CS2 REV 11

    MDR report key: 18121631 · Received November 9, 2023

    Report

    Report Number
    MW5148039
    Event Type
    Malfunction
    Date Received
    November 9, 2023
    Date of Event
    September 27, 2023
    Report Date
    November 7, 2023
    Manufacturer
    GE HEALTHCARE / GE MEDICAL SYSTEMS (CHINA) CO., LTD.
    Product Code
    BSZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    SEVOFLURANE APPEARED ON THE GAS ANALYZER. THESE MACHINES HAVE A DEFECT WHICH NEEDS TO BE ADDRESSED BY THE COMPANY AS A RECALL. THE SEVOFLURANE THAT IS "LEAKING" IS NOT BEING PROPERLY SCAVENGED AND IS AN ENVIRONMENTAL AND HEALTH HAZARD FOR OUR EMPLOYEES AND PATIENTS. SHOULD WE INVOLVE RISK MANAGEMENT AND OCCUPATIONAL HEALTH? I SUSPECT IT IS ALSO AN OSHA AND JC VIOLATION. IN ADDITION, IF A CHART GOES UNDER LEGAL REVIEW FOR ANY REASON WE WILL HAVE TO EXPLAIN THIS ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1989345 GE HEALTHCARE AISYS CS2 REV 11 GAS-MACHINE, ANESTHESIA BSZ GE HEALTHCARE / GE MEDICAL SYSTEMS (CHINA) CO., LTD. AISYS CS2

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other