BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENVE

    MDR report key: 4916605 · Received July 15, 2015

    Report

    Report Number
    2031702-2015-00135
    Event Type
    Malfunction
    Date Received
    July 15, 2015
    Report Date
    July 15, 2015
    Manufacturer
    CAREFUSION 203, INC
    Product Code
    CBK
    PMA / PMN Number
    K070594
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER WAS UNABLE TO DUPLICATE THE REPORTED PROBLEM. THE VENTILATOR PASSED AN EXTENDED TEST RUN USING THE CUSTOMER¿S VENTILATOR SETTINGS. THE VENTILATOR ALSO PASSED THE INITIAL FINAL TEST AND THE INITIAL ALARM VOLUME TESTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTILATOR'S EXHALED VOLUMES WERE LOW WHILE IT WAS CONNECTED TO A PATIENT. EVEN THOUGH THE PATIENT CIRCUIT WAS REPLACED TWICE ALONG WITH THE EXHALATION DIAPHRAGM AND THE VENTILATOR HAD PASSED THE LEAK TEST, THE PROBLEM WAS NOT CORRECTED. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND PLACED ON ANOTHER VENTILATOR WITH NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    459777 ENVE VENTILATOR, CONTINUOUS CBK CAREFUSION 203, INC 19250-001

    Patients

    Seq Age Sex Outcome Treatment
    1