BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V200 VENTILATOR

    MDR report key: 4123472 · Received September 26, 2014

    Report

    Report Number
    2031642-2014-01112
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Report Date
    September 2, 2014
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    CBK
    PMA / PMN Number
    K102054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE VENTILATOR ALARMED AND RESTARTED DURING NORMAL VENTILATION OPERATION. THE CUSTOMER REPORTED THE DEVICE WAS IN USE AND THERE WAS NO PATIENT HARM. THE MANUFACTURERS FIELD SERVICE ENGINEER (FSE) WAS UNABLE TO DUPLICATE THE REPORTED PROBLEM. THE FSE REPORTED REVIEW OF THE DEVICE DIAGNOSTIC HISTORY NOTED A RESTART AS REPORTED BY THE CUSTOMER. THE SERVICE ENGINEER REPLACED THE POWER SWITCH AS A PRECAUTION TO ADDRESS THE FINDING. APPLICABLE FINAL TESTING WAS COMPLETED PER OPERATING SPECIFICATIONS. THE CUSTOMER REPORTED THE UNIT WAS RUN-IN BEFORE PLACING BACK IN SERVICE WITH NO RECURRENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600096 V200 VENTILATOR VENTILATOR, CONTINUOUS CBK RESPIRONICS CALIFORNIA, INC. V200 NA

    Patients

    Seq Age Sex Outcome Treatment
    1