BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V200 VENTILATOR

    MDR report key: 3964553 · Received July 29, 2014

    Report

    Report Number
    2031642-2014-00755
    Event Type
    Malfunction
    Date Received
    July 29, 2014
    Report Date
    July 7, 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 COULD NOT OPERATE ON AC POWER BUT WOULD OPERATE ON BATTERY POWER. THE CUSTOMER REPORTED THE DEVICE WAS NOT IN USE ON A PATIENT THEREFORE THERE WAS NO PATIENT INVOLVEMENT OR HARM. THE MANUFACTURERS SERVICE PROVIDER CONFIRMED THE REPORTED PROBLEM. THE SERVICE PROVIDER REPLACED THE POWER SUPPLY TO ADDRESS THE REPORTED PROBLEM. POWER FAILURE DUE TO LOSS OF AC OR BATTERY POWER MAY RESULT IN SHUTDOWN OF DEVICE DURING NORMAL VENTILATION OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441387 V200 VENTILATOR VENTILATOR, CONTINOUS CBK RESPIRONICS CALIFORNIA, INC. V200 NA

    Patients

    Seq Age Sex Outcome Treatment
    1