BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V200 VENTILATOR

    MDR report key: 3833869 · Received May 27, 2014

    Report

    Report Number
    2031642-2014-00397
    Event Type
    Malfunction
    Date Received
    May 27, 2014
    Report Date
    December 6, 2024
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    CBK
    PMA / PMN Number
    K102054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    RESPIRATORY THERAPIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE VENTILATOR ALARMED AND SCREEN WENT BLANK DURING NORMAL VENTILATION OPERATION. THE CUSTOMER REPORTED THE DEVICE WAS IN USE ON A PATIENT AND THERE WAS NO PATIENT HARM. THE MANUFACTURERS FIELD SERVICE ENGINEER WAS UNABLE TO DUPLICATE THE REPORTED PROBLEM. REVIEW OF THE DEVICE DIAGNOSTIC HISTORY NOTED AN AIR SOURCE FAULT FOLLOWED BY AN OXYGEN VALVE STUCK CLOSED OCCURRENCE. LOSS OF BOTH GAS SUPPLIES WILL AFFECT THE FUNCTION OF THE VENTILATOR. IF THE VENTILATOR IS OPERATING IN NORMAL VENTILATION MODE AND NO AIR FLOW IS DETECTED, AND THE VENTILATOR CANNOT SWITCH TO AN OXYGEN SOURCE, THE VENTILATOR WILL ALARM AND THE SAFETY VALVE WILL OPEN. THE SERVICE ENGINEER REPLACED THE MAIN PCB BOARD AS A PRECAUTION TO ADDRESS THE FINDING. PERFORMANCE VERIFICATION TESTING WAS COMPLETED AND PASSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311645 V200 VENTILATOR VENTILATOR, CONTINUOUS CBK RESPIRONICS CALIFORNIA, INC. V200 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Male