BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V200 VENTILATOR

    MDR report key: 3870697 · Received June 12, 2014

    Report

    Report Number
    2031642-2014-00489
    Event Type
    Malfunction
    Date Received
    June 12, 2014
    Report Date
    May 19, 2014
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    CBK
    PMA / PMN Number
    K102054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VM
    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. THE FAILURE AS NOTED MAY RESULT IN A LOSS OF AC POWER DURING NORMAL VENTILATION 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 WOULD NOT OPERATE VIA AC POWER AND THE MAINS POWER LED INDICATOR WAS BLINKING. THE CUSTOMER REPORTED THE DEVICE WAS NOT IN USE ON A PATIENT THEREFORE THERE WAS NO PATIENT INVOLVEMENT OR HARM. THE MANUFACTURERS FIELD SERVICE ENGINEER CONFIRMED THE REPORTED PROBLEM. THE SERVICE ENGINEER REPORTED THE POWER SUPPLY WILL BE REPLACED TO ADDRESS THE REPORTED PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348337 V200 VENTILATOR VENTILATOR, CONTINUOUS CBK RESPIRONICS CALIFORNIA, INC. V200 NA

    Patients

    Seq Age Sex Outcome Treatment
    1