BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GE CARESTATION 650 ANESTHESIA MACHINE

    MDR report key: 22809642 · Received August 14, 2025

    Report

    Report Number
    MW5174573
    Event Type
    Malfunction
    Date Received
    August 14, 2025
    Date of Event
    March 24, 2022
    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 NOT RELEASING AIRWAY PRESSURE IN BAG MODE. PATIENT WAS SPONTANEOUSLY BREATH; APL VALVE WAS SET AT MINIMUM AND REBREATHING BAG HAD TO BE REMOVED TO RELEASE AIRWAY PRESSURE TO PREVENT POTENTIAL BAROTRAUMA TO PATIENT. HOSPITAL BIO MED CALLED GE. IT WAS DECIDED BETWEEN DIFFERENT DEPARTMENTS TO REPLACE 02 FLUSH MANIFOLD AND MICROSWITCH. MACHINE WAS TESTED AND PERFORMED ALL CALIBRATIONS. MACHINE RELEASED BACK INTO SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1679904 GE CARESTATION 650 ANESTHESIA MACHINE GAS-MACHINE, ANESTHESIA BSZ GE HEALTHCARE TECHNOLOGIES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown