BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVOLUTION 3E VENTILATOR

    MDR report key: 4987807 · Received August 10, 2015

    Report

    Report Number
    3006135941-2015-00009
    Event Type
    Malfunction
    Date Received
    August 10, 2015
    Date of Event
    August 7, 2015
    Report Date
    August 7, 2015
    Manufacturer
    EVENT MEDICAL LTD.
    Product Code
    CBK
    PMA / PMN Number
    K113743
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GT
    Reporter Occupation
    SERVICE PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE (EVOLUTION 3E VENTILATOR) IS NOT DISTRIBUTED IN THE USA.

    Description of Event or Problem · 1

    FLOW SENSOR ERROR ALARM MESSAGE ON SCREEN. THE DOCTOR REMOVED THE VENTILATOR FROM SERVICE AND USED A DIFFERENT VENTILATOR

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    521969 EVOLUTION 3E VENTILATOR VENTILATOR CBK EVENT MEDICAL LTD. EVOLUTION 3E VENTILATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention