BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARESTATION 750

    MDR report key: 23465066 · Received November 4, 2025

    Report

    Report Number
    9710602-2025-03720
    Event Type
    Malfunction
    Date Received
    November 4, 2025
    Date of Event
    October 7, 2025
    Report Date
    November 4, 2025
    Manufacturer
    GE MEDICAL SYSTEMS (CHINA) CO., LTD (WUXI)
    Product Code
    BSZ
    UDI-DI
    00840682145596
    PMA / PMN Number
    K213867
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A GE HEALTHCARE SERVICE REPRESENTATIVE PERFORMED A CHECKOUT OF THE SYSTEM AND CONFIRMED THE REPORTED ISSUE. THE KPI REGULATOR VALVE WAS REPLACED TO RESOLVE THE ISSUE. BLOCK A: NO REPORT OF PATIENT INVOLVEMENT. LEGAL MANUFACTURER: HCS MADISON - 3030 OHMEDA DR, USA MADISON, WI 53718.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS A MALFUNCTION RESULTING IN LOSS OF MECHANICAL VENTILATION. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1698599 CARESTATION 750 ANESTHESIA GAS MACHINE BSZ GE MEDICAL SYSTEMS (CHINA) CO., LTD (WUXI) A1 NA 00840682145596

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown