BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V200 VENTILATOR

    MDR report key: 4232973 · Received November 6, 2014

    Report

    Report Number
    2031642-2014-01373
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Report Date
    October 16, 2014
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    CBK
    PMA / PMN Number
    K102054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE INTERNATIONAL CUSTOMER REPORTED THE VENTILATOR COULD NOT BOOT UP. THE CUSTOMER REPORTED THE DEVICE WAS NOT IN USE THEREFORE THERE WAS NO PATIENT INVOLVEMENT. 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
    715739 V200 VENTILATOR VENTILATOR, CONTINUOUS CBK RESPIRONICS CALIFORNIA, INC. V200 NA

    Patients

    Seq Age Sex Outcome Treatment
    1