BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDIVITOP

    MDR report key: 22035204 · Received May 16, 2025

    Report

    Report Number
    3003207908-2025-00001
    Event Type
    Malfunction
    Date Received
    May 16, 2025
    Date of Event
    February 1, 2025
    Report Date
    July 14, 2025
    Manufacturer
    GCE, S.R.O.
    Product Code
    CAN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    MIDLANDS AIR AMBULANCE CHARITY REPORTED TO MHRA - MEDICINES & HEALTHCARE PRODUCTS REGULATORY AGENCY, UNITED KINGDOM: PATIENT WAS ANAESTHETISED, VENTILATED AND TRANSPORTED TO HOSPITAL BY AIR. THE FLIGHT WAS APPROXIMATELY 20 MINUTES. PRIOR TO TAKE OFF THE CYLINDER WAS CHANGED TO A FULL ONE, THEREFORE, THE QUANTITY OF OXYGEN AVAILABLE IN THE CYLINDER SHOULD HAVE SUFFICIENT. ON ARRIVAL AT HOSPITAL AND WHEN TRANSFERRING THE PATIENT FROM THE AIRCRAFT TO THE RESUSROOM (APPROX 30 METRES) THE VENTILATOR ALARMED AND THE CYLINDER WAS IDENTIFIED AS EMPTY.

    Description of Event or Problem · 0

    (B)(6) REPORTED TO MHRA - MEDICINES & HEALTHCARE PRODUCTS REGULATORY AGENCY, UNITED KINGDOM: PATIENT WAS ANAESTHETISED, VENTILATED AND TRANSPORTED TO HOSPITAL BY AIR. THE FLIGHT WAS APPROXIMATELY 20 MINUTES. PRIOR TO TAKE OFF THE CYLINDER WAS CHANGED TO A FULL ONE, THEREFORE THE QUANTITY OF OXYGEN AVAILABLE IN THE CYLINDER SHOULD HAVE SUFFICIENT. ON ARRIVAL AT HOSPITAL AND WHEN TRANSFERRING THE PATIENT FROM THE AIRCRAFT TO THE RESUSROOM (APPROX 30 METRES) THE VENTILATOR ALARMED AND THE CYLINDER WAS IDENTIFIED AS EMPTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451176 MEDIVITOP VIPR CAN GCE, S.R.O.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other