BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 3961663 · Received July 28, 2014

    Report

    Report Number
    2031642-2014-00750
    Event Type
    Malfunction
    Date Received
    July 28, 2014
    Report Date
    July 3, 2014
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    CBK
    PMA / PMN Number
    K981072
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AIR FLOW SENSOR.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE VENTILATOR WAS ALARMING ON POWER UP DUE TO A VENT INOP AIR VALVE LIFTOFF FAILURE. THE DEVICE WAS NOT IN USE ON A PATIENT THEREFORE THERE WAS NO PATIENT INVOLVEMENT OR HARM. DURING EVALUATION, THE MANUFACTURERS FIELD SERVICE ENGINEER (FSE) REPORTED THE DEVICE POWERED UP BUT THE BLOWER STOPPED SPINNING AND IT WENT VENT INOP AS REPORTED. THE FSE REPORTED THE PROBLEM IS INTERMITTENT AND THE DEVICE IS OPENED FOR EVALUATION THERE WAS NO PROBLEM FOUND. THE FSE REPLACED THE AIR FLOW SENSOR AND CABLE AS A PRECAUTION TO ADDRESS THE REPORTED PROBLEM. APPLICABLE FINAL TESTING WAS PERFORMED PER OPERATING SPECIFICATIONS AND PASSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439125 ESPRIT VENTILATOR VENTILATOR, CONTINUOUS CBK RESPIRONICS CALIFORNIA, INC. V1000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1