BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GE CARESTATION 650 ANESTHESIA MACHINE

    MDR report key: 22817159 · Received August 15, 2025

    Report

    Report Number
    MW5174636
    Event Type
    Malfunction
    Date Received
    August 15, 2025
    Date of Event
    September 1, 2023
    Report Date
    August 12, 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

    ADJUSTABLE PRESSURE LIMITING VALVE NOT RELEASING AIRWAY PRESSURE IN BAG MODE DURING SPONTANEOUS BREATHING. CLINICIAN HAD TO REMOVE REBREATHING BAG DURING PROCEDURE TO RELEASE AIRWAY PRESSURE TO PREVENT POTENTIAL BAROTRAUMA TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1628174 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