BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GE CARESTATION 650 ANESTHESIA MACHINE

    MDR report key: 22809437 · Received August 14, 2025

    Report

    Report Number
    MW5174564
    Event Type
    Malfunction
    Date Received
    August 14, 2025
    Date of Event
    August 7, 2023
    Report Date
    August 11, 2025
    Manufacturer
    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

    APL VALVE STICKING WHEN SET AT MINIMUM. PATIENT SPONTANEOUS BREATHING AND AIRWAY PRESSURE WOULD INCREASE. CLINICIAN HAD TO REMOVE REBREATHING BAG TO PREVENT POTENTIAL BAROTRAUMA TO PATIENT DURING PROCEDURE. VIDEO OF EVENT WAS PROVIDED TO BOTH HOSPITAL BIO MED TEAM AND GE HEALTHCARE. HOSPITAL BIO MED TEAM WAS ABLE TO REPRODUCE EVENT. AFTER APPLYING FORCE TO THE REBREATHING BAG A "POP" WAS HEARD AND FELT. HOSPITAL BIOMED TEAM CLEANED ALL PNEUMATIC COMPONENT'S AND COULD NOT REPRODUCE. MACHINE WAS RETURNED TO SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1679895 GE CARESTATION 650 ANESTHESIA MACHINE GAS-MACHINE, ANESTHESIA BSZ GE HEALTHCARE TECHNOLOGIES, INC. CARESTATION 650

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown