BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V200

    MDR report key: 3972843 · Received July 8, 2014

    Report

    Report Number
    2031642-2014-00628
    Event Type
    Malfunction
    Date Received
    July 8, 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
    IN
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE INTERNATIONAL CUSTOMER REPORTED THE VENTILATOR WON'T CHANGE THE BACK UP BATTERY DURING NORMAL VENTILATION OPERATION. 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 MANUFACTURERS FIELD SERVICE ENGINEER EVALUATED THE DEVICE AND REPLACED THE POWER SUPPLY TO ADDRESS THE REPORTED PROBLEM. THE DEVICE PASSED ALL MANUFACTURER REQUIRED TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    397922 V200 VENTILATOR, CONTINUOUS CBK RESPIRONICS CALIFORNIA, INC. V200 NA

    Patients

    Seq Age Sex Outcome Treatment
    1