BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVITA INFINITY V500

    MDR report key: 3850497 · Received May 29, 2014

    Report

    Report Number
    3850497
    Event Type
    Malfunction
    Date Received
    May 29, 2014
    Date of Event
    March 18, 2014
    Report Date
    May 29, 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

    PATIENT'S VENTILATOR ALARMING "INTERNAL POWER FAILURE" AS WELL AS "BATTERY FAILURE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    316840 EVITA INFINITY V500 VENTILATOR, CONTINUOUS, FACILITY USE CBK DRAEGER MEDICAL, INC. V500 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR