BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V200 VENTILATOR

    MDR report key: 2024164 · Received March 18, 2011

    Report

    Report Number
    2031642-2011-00066
    Event Type
    Malfunction
    Date Received
    March 18, 2011
    Date of Event
    February 18, 2011
    Report Date
    February 22, 2011
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    CBK
    PMA / PMN Number
    K102054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE VENTILATOR HAD AN OXYGEN FLOW FAILURE DURING OPERATION. UPON EVALUATION AND INITIAL TESTING, THE MANUFACTURER'S SERVICE TECHNICIAN REPORTED THE UNIT WOULD INDICATE THAT OXYGEN WAS NOT CONNECTED WHEN THERE WAS AN OXYGEN HOSE CONNECTED TO AN OXYGEN SOURCE. THE SERVICE TECHNICIAN CHECKED THE OXYGEN HOSE AND REPORTED IT WAS KINKED. THE SERVICE TECHNICIAN REPLACED THE OXYGEN HOSE AND REPEAT TESTING PASSED. THE CUSTOMER REPORTED NO PATIENT HARM. IF THE VENTILATOR IS OPERATING AND NO AIR FLOW IS DETECTED, AND THE OXYGEN SOURCE IS NOT DETECTED BY THE OXYGEN PRESSURE SWITCH OR IS DISCONNECTED, THE VENTILATOR WILL ALARM AND THE SAFETY VALVE WILL OPEN. PERFORMANCE VERIFICATION TESTING WAS COMPLETED AND TESTS PASSED TO OPERATING SPECIFICATIONS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1