BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVOLUTION 3E T

    MDR report key: 4966172 · Received August 4, 2015

    Report

    Report Number
    3006135941-2015-00007
    Event Type
    Malfunction
    Date Received
    August 4, 2015
    Manufacturer
    EVENT MEDICAL LTD.
    Product Code
    CBK
    PMA / PMN Number
    K113743
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT (EVOLUTION 3E VENTILATORS) IS NOT DISTRIBUTED IN THE USA.

    Description of Event or Problem · 1

    FLOW SENSOR ERROR DURING VENTILATION. ALSO, EXHALATION FLOW SENSOR CALIBRATION IS FAILING AT 130LPM; VENTILATOR IS NOT PROVIDING SUFFICIENT AIR FLOW TO COMPLETE THE CALIBRATION

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    511715 EVOLUTION 3E T CONTINUOUS VENTILATOR CBK EVENT MEDICAL LTD. EVOLUTION 3E T

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention