BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVOLUTION 3E VENTILATOR SYSTEM

    MDR report key: 4924359 · Received July 16, 2015

    Report

    Report Number
    3006135941-2015-00005
    Event Type
    Malfunction
    Date Received
    July 16, 2015
    Date of Event
    June 18, 2015
    Report Date
    July 16, 2015
    Manufacturer
    EVENT MEDICAL LTD.
    Product Code
    CBK
    PMA / PMN Number
    K113743
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS NOT DISTRIBUTED IN THE USA.

    Description of Event or Problem · 1

    HOSP. INFORMED US THAT AFTER ABOUT 5 HOURS RUNNING ON THEIR PATIENT. THERE WAS "TF-02, BLOWER FAILURE" ALARM AND IT STOPPED VENTILATING. SO THEY HAVE TRIED TO RESTART IT MANY TIMES BUT STILL GOT THAT ALARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    464027 EVOLUTION 3E VENTILATOR SYSTEM CBK EVENT MEDICAL LTD. 5I

    Patients

    Seq Age Sex Outcome Treatment
    1