BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARESTATION 650

    MDR report key: 22007895 · Received May 13, 2025

    Report

    Report Number
    9710602-2025-00934
    Event Type
    Malfunction
    Date Received
    May 13, 2025
    Date of Event
    April 15, 2025
    Report Date
    May 13, 2025
    Manufacturer
    GE MEDICAL SYSTEMS (CHINA) CO., LTD (WUXI)
    Product Code
    BSZ
    UDI-DI
    00840682103947
    PMA / PMN Number
    K151570
    Removal / Correction Number
    SEE H11
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    HGE HEALTHCARE (GEHC) REPORTED A FIELD MODIFICATION FOR AN ISSUE THAT PREVENTS EFFECTIVE MECHANICAL VENTILATION IN VOLUME CONTROL VENTILATION (VCV) MODE PER 21 CFR 806 ON (B)(6) 2025. THE FDA RECALL NUMBERS ARE: Z-1624-2025, Z-1625-2025, Z-1626-2025, Z-1627-2025, Z-1628-2025, Z-1629-2025, Z-1630-2025, Z-1631-2025, Z-1632-2025, Z-1633-2025, Z-1634-2025, Z-1635-2025, Z-1636-2025, Z-1637-2025, Z-1638-2025. CUSTOMERS WERE SENT A LETTER EXPLAINING THE ISSUE AND PROVIDING INSTRUCTIONS FOR INSPECTING FOR EFFECTIVE VENTILATION IN VOLUME CONTROL VENTILATION (VCV) MODE. GEHC WILL CORRECT ALL DEVICES THAT FAIL THE VENTILATION SCREENING TEST AT NO COST. BLOCK A: NO PATIENT INVOLVEMENT. LEGAL MANUFACTURER: HCS MADISON - 3030 OHMEDA DR, USA MADISON, WI 53718.

    Description of Event or Problem · 0

    AS A RESULT OF AN INSPECTION THAT WAS COMPLETED AS PART OF THE CORRECTION INITIATED BY GE HEALTHCARE (GEHC) ON (B)(6) 2025, (GEHC FIELD ACTION NUMBER (B)(4)) THIS UNIT WAS IDENTIFIED AS HAVING AN ISSUE THAT PREVENTS EFFECTIVE MECHANICAL VENTILATION IN VOLUME CONTROL VENTILATION (VCV) MODE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2370679 CARESTATION 650 ANESTHESIA GAS MACHINE BSZ GE MEDICAL SYSTEMS (CHINA) CO., LTD (WUXI) A1 NA 00840682103947

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown