BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V200 VENTILATOR

    MDR report key: 3971365 · Received July 31, 2014

    Report

    Report Number
    2031642-2014-00769
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Report Date
    July 15, 2014
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    CBK
    PMA / PMN Number
    K102054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    THE INTERNATIONAL CUSTOMER REPORTED THE VENTILATOR FAILED PRE-OPERATIONAL SYSTEM PRESSURE TESTING. THE VENTILATOR WAS NOT IN USE ON A PATIENT THEREFORE THERE WAS NO PATIENT INVOLVEMENT. THE MANUFACTURERS SERVICE ASSOCIATE CONFIRMED THE REPORTED PROBLEM AND REPORTED THE THREE STATION SOLENOID WAS REPLACED TO ADDRESS THE REPORTED PROBLEM. FAILURE OF THE THREE STATION SOLENOID MAY RESULT IN A LEAK OR THE SAFETY VALVE NOT CLOSING, AND PREOPERATIONAL SELF TESTING WILL NOT PASS AS NOTED. A MALFUNCTION OF THE THREE STATION SOLENOID DURING NORMAL VENTILATION OPERATION MODE MAY RESULT IN PRESSURE OR VOLUME LOSS AND MAY BE DETRIMENTAL TO A PATIENT IF IN USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446774 V200 VENTILATOR VENTILATOR, CONTINUOUS CBK RESPIRONICS CALIFORNIA, INC. V200 NA

    Patients

    Seq Age Sex Outcome Treatment
    1