BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GE CARESTATION 650 ANESTHESIA MACHINE

    MDR report key: 22809430 · Received August 14, 2025

    Report

    Report Number
    MW5174563
    Event Type
    Malfunction
    Date Received
    August 14, 2025
    Date of Event
    March 2, 2022
    Report Date
    August 11, 2025
    Manufacturer
    DATEX-OHMEDA, INC./GE HEALTHCARE TECHNOLOGIES INC.
    Product Code
    BSZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    CARESTATION 650 ANESTHESIA MACHINE APL VALVE (ADJUSTABLE PRESSURE LIMITING VALVE) WAS SET AT MINIMUM WHILE PATIENT WAS SPONTANEOUSLY BREATHING, AND AIRWAY PRESSURES BEGAN TO INCREASE. CLINICIAN HAD TO REMOVE THE REBREATHING BAG TO RELEASE THE AIRWAY PRESSURES UNTIL CASE WAS COMPLETED. HOSPITAL BIO MED TEAM DISASSEMBLED ANESTHETIC GAS SCAVENGING SYSTEMS ASSEMBLY AND CHECKED FOR BLOCKAGES/LEAKS. TESTED APL VALVE FROM MINIMUM TO 70. HOSPITAL CALLED GENERAL ELECTRIC TECHNOLOGY TECH SUPPORT ON 3/03/2022 ORDERED PARTS TO REPLACE BAG-TO-VENT MODULE AND APL ASSEMBLY. PERFORMED PREVENTATIVE MAINTENANCE AND RETURNED TO SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1679894 GE CARESTATION 650 ANESTHESIA MACHINE GAS-MACHINE, ANESTHESIA BSZ DATEX-OHMEDA, INC./GE HEALTHCARE TECHNOLOGIES INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown