BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V200

    MDR report key: 3945548 · Received July 7, 2014

    Report

    Report Number
    2031642-2014-00625
    Event Type
    Malfunction
    Date Received
    July 7, 2014
    Report Date
    June 13, 2014
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    CBK
    PMA / PMN Number
    K102054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    FACTORY ANALYSIS OF THE RETURNED POWER SUPPLY REVEALED A BRIDGE RECTIFIER SHORT THAT RESULTED IN THE REPORTED POWER ISSUE. EVALUATION OF THE COMPONENT NOTED HEAT RELATED DAMAGE. THE FAILURE AS NOTED MAY RESULT IN A LOSS OF AC POWER DURING NORMALVENTILATION OPERATION. IF A FAILURE OF THE POWER SUPPLY OCCURS DURING USE AND THE VENTILATOR SHUTS DOWN DUE TO A LOSS OF AC POWER, AN AUDIBLE POWER FAIL ALARM WILL ACTIVATE.

    Description of Event or Problem · 1

    THE INTERNATIONAL CUSTOMER REPORTED THE VENTILATOR CANNOT WORK ON AC POWER DURING NORMAL VENTILATION OPERATION. THE CUSTOMER REPORTED THE DEVICE WAS NOT IN USE ON A PT; THEREFORE, THERE WAS NO PT INVOLVEMENT OR HARM. THE MANUFACTURERS FIELD SVC ENGINEER STATED THE UNIT POWER UP WAS INTERMITTENT ON BOTH AC AND DC AND SOMETIMES IT ONLY WORKED ON BATTERY. THE MANUFACTURERS FIELD SVC ENGINEER EVALUATED THE DEVICE AND REPLACED THE POWER SUPPLY TO ADDRESS THE REPORTED PROBLEM. THE DEVICE PASSED THE MANUFACTURER REQUIRED TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    393114 V200 VENTILATOR, CONTINUOUS CBK RESPIRONICS CALIFORNIA, INC. V200 NA

    Patients

    Seq Age Sex Outcome Treatment
    1