BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V200 VENTILATOR

    MDR report key: 4025267 · Received August 20, 2014

    Report

    Report Number
    2031642-2014-00873
    Event Type
    Malfunction
    Date Received
    August 20, 2014
    Report Date
    July 28, 2014
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    CBK
    PMA / PMN Number
    K102054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    SUPPLEMENTAL REPORT

    Additional Manufacturer Narrative · 1

    CUSTOMER HAS NOT PURCHASED PART FOR REPAIR.

    Description of Event or Problem · 1

    THE INTERNATIONAL CUSTOMER REPORTED DURING ROUTINE TESTING THE VENTILATOR WOULD NOT POWER ON. THE CUSTOMER REPORTED THE DEVICE WAS NOT IN USE ON A PATIENT THEREFORE THERE WAS NO PATIENT INVOLVEMENT OR HARM. THE MANUFACTURERS SERVICE ENGINEER REPORTED THE POWER SUPPLY WAS NOT FUNCTIONAL. POWER FAILURE DUE TO LOSS OF AC OR BATTERY POWER MAY RESULT IN SHUTDOWN OF DEVICE DURING NORMAL VENTILATION OPERATION. PROPER CARE, MAINTENANCE AND TESTING SHOULD BE PERFORMED WHEN USING BATTERY POWER SOURCES. AN ESTIMATE FOR THE POWER SUPPLY REPLACEMENT WAS PROVIDED TO THE CUSTOMER BUT THE CUSTOMER HAS NOT PURCHASED THE PART.

    Description of Event or Problem · 1

    THE MANUFACTURERS SERVICE ENGINEER REPLACED THE POWER SUPPLY TO ADDRESS THE REPORTED PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    502884 V200 VENTILATOR VENTILATOR, CONTINOUS CBK RESPIRONICS CALIFORNIA, INC. V200 NA

    Patients

    Seq Age Sex Outcome Treatment
    1