BEUDAMED
    FDA Adverse Event Death Summary report: N

    AISYS

    MDR report key: 21690231 · Received March 25, 2025

    Report

    Report Number
    2112667-2025-02474
    Event Type
    Death
    Date Received
    March 25, 2025
    Date of Event
    February 6, 2025
    Report Date
    June 19, 2025
    Manufacturer
    DATEX-OHMEDA, INC.
    Product Code
    BSZ
    PMA / PMN Number
    K172045
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    GE HEALTHCARE'S (GEHC) INVESTIGATION HAS BEEN COMPLETED AND THE ROOT CAUSE COULD NOT BE DETERMINED. THE GEHCÂ'S FIELD ENGINEER COMPLETED A REVIEW OF THE SYSTEM LOGS AND DETERMINED THERE WAS NO MALFUNCTION OF THE GEHC DEVICE. THEREFORE, THE ROOT CAUSE OF THE PATIENT DEATH IS UNDETERMINED.

    Additional Manufacturer Narrative · 0

    GE HEALTHCARE INVESTIGATION INTO THE REPORTED OCCURRENCE IS ONGOING. A FOLLOW-UP REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAS BEEN COMPLETED. BLOCK A5 AND A6: NO INFORMATION PROVIDED. D4 PRIMARY UDI NUMBER: THERE IS NO UDI AVAILABLE AS THE DEVICE WAS MANUFACTURED PRIOR TO UDI COMPLIANCE REQUIREMENTS. LEGAL MANUFACTURER: HCS MADISON - 3030 OHMEDA DR, USA MADISON, WI 53718.

    Description of Event or Problem · 0

    THE HOSPITAL REPORTED DIFFICULTY VENTILATING A PATIENT CONNECTED TO AN AISYS. ALLEGEDLY, THE UNIT STOPPED VENTILATING. IT WAS REPORTED THAT THE PATIENT DIED. GE HEALTHCARE WILL SUBMIT A FOLLOW-UP REPORT WHEN THE INVESTIGATION HAS BEEN COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1319205 AISYS ANESTHESIA GAS MACHINE BSZ DATEX-OHMEDA, INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female Death