BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GO2VENT

    MDR report key: 19228757 · Received May 2, 2024

    Report

    Report Number
    19228757
    Event Type
    Malfunction
    Date Received
    May 2, 2024
    Date of Event
    December 4, 2023
    Report Date
    January 2, 2024
    Manufacturer
    VORTRAN MEDICAL TECHNOLOGY 1, INC.
    Product Code
    BTL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT BROUGHT INTO MAGNETIC RESONANCE IMAGING (MRI) ROOM ON VORTRAN AND TRANSFERRED TO MRI TABLE. PATIENT WAS TOLERATING VORTRAN WELL UNTIL VORTRAN PRESSURE MONOMETER SUDDENLY STOPPED AND PATIENT WAS NO LONGER BREATHING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    846706 GO2VENT VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR) BTL VORTRAN MEDICAL TECHNOLOGY 1, INC. 6123 2311 GCM-A

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Unknown