BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVITA INFINITY

    MDR report key: 3962857 · Received July 17, 2014

    Report

    Report Number
    3962857
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Date of Event
    March 10, 2014
    Report Date
    July 17, 2014
    Manufacturer
    DRAEGER MEDICAL, INC.
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    VENTILATOR WAS READING 93% OXYGEN LEVEL, WHEN IT WAS SET ON 100% FIO2, VENT WAS CHANGED OUT AND TAKEN DOWN FOR MAINTENANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    420390 EVITA INFINITY VENTILATOR, CONTINUOUS, FACILITY USE CBK DRAEGER MEDICAL, INC. V500 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR NOT APPLICABLE.