BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVITA INFINITY V500

    MDR report key: 12301126 · Received August 10, 2021

    Report

    Report Number
    12301126
    Event Type
    Malfunction
    Date Received
    August 10, 2021
    Date of Event
    July 23, 2021
    Report Date
    August 2, 2021
    Manufacturer
    DRAEGER MEDICAL SYSTEMS, INC.
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DR¿GER EVITA¿ INFINITY¿ V500 VENTILATOR DISPLAYING AIRWAY OBSTRUCTION. PRESSURE LIMITED TIDAL VOLUME NOT REACHED. PATIENT OXYGEN DESATURATED TO 24%. PATIENT BAGGED AND PLACED ON REPLACEMENT VENTILATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1201073 EVITA INFINITY V500 VENTILATOR, CONTINUOUS, FACILITY USE CBK DRAEGER MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 17885 DA