BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVOLUTION 3E T

    MDR report key: 4966151 · Received August 4, 2015

    Report

    Report Number
    3006135941-2015-00008
    Event Type
    Malfunction
    Date Received
    August 4, 2015
    Date of Event
    June 18, 2015
    Report Date
    August 4, 2015
    Manufacturer
    EVENT MEDICAL LTD.
    Product Code
    CBK
    PMA / PMN Number
    K113743
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    - HOSPITAL INFORMED US THAT AFTER ABOUT 5 HOURS RUNNING ON THEIR PATIENT, THERE WAS "TF-02, BLOWER FAILURE" ALARM AND IT STOP VENTILATING. SO THEY HAVE TRIED TO RESTART IT MANY TIME BUT STILL GOT THAT ALARM. - 3 DAYS LATER WE VISITED THE HOSPITAL AND TRIED TO POWER ON AND IT RAN OKAY AT THE BEGINNING. BUT WHEN WE CYCLED FEW TIMES AND WENT TO "PATIENT SETUP" SCREEN THEN THE "TF-02, BLOWER FAILURE" OCCURS AGAIN. - WE HAVE REPLACED A GOOD CONTROL BOARD AND RUN IT ON THIS FAULTY VENTILATOR FOR ABOUT 05 DAYS CONTINUOUS AND THE RESULT IS THE VENTILATOR STILL OPERATING NORMALLY. - WE HAVE CHECKED REVERSE: WE HAVE CHECKED THE SUSPECTED FAULTY CONTROL BOARD ON THE GOOD VENTILATOR EVOLUTION 3E AND THE RESULT IS THE MACHINE STILL HAPPEN THIS ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    511225 EVOLUTION 3E T CONTINUOUS VENTILATOR CBK EVENT MEDICAL LTD. EVOLUTION 3E T

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention