BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVITA INFINITY V500

    MDR report key: 4143247 · Received September 19, 2014

    Report

    Report Number
    4143247
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    April 21, 2014
    Report Date
    August 19, 2014
    Manufacturer
    DRAEGER MEDICAL SYSTEMS, INC.
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS LETHARGIC AND PLACED BACK ON VENTILATOR, AND "VENT FAILURE" ALARM OCCURRED. PATIENT BAGGED AND VENTILATOR WAS SWITCHED OUT.FROM BIOMED REVIEW: THIS V500 GENERATED AN "ALARM SYSTEM FAILURE" ALARM WHILE IN USE. REQUESTED ONSITE TECH SUPPORT FROM DRAEGER. WOULD RECOMMEND REPORTING THIS AS IT INTERRUPTED PATIENT CARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583385 EVITA INFINITY V500 VENTILATOR, CONTINUOUS, FACILITY USE CBK DRAEGER MEDICAL SYSTEMS, INC. V500 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR