BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLV CONTINUUM II VENTILATOR

    MDR report key: 1312152 · Received February 17, 2009

    Report

    Report Number
    2031642-2009-00051
    Event Type
    Malfunction
    Date Received
    February 17, 2009
    Date of Event
    January 23, 2009
    Report Date
    January 23, 2009
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    CBK
    PMA / PMN Number
    K034032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PRODUCT CODE: NOU

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE FLOW SENSOR CONNECTOR WOULD NOT LATCH INTO THE FLOW SENSOR PORT PROPERLY. THE VENTILATOR WAS NOT IN USE AT THE TIME OF THE REPORTED PROBLEM, THEREFORE THERE WAS NO PATIENT HARM OR INVOLVEMENT. WHEN A FLOW SENSOR LINE DISCONNECTION OCCURS DURING NORMAL VENTILATION, THE VENTILATOR WILL ACTIVATE AN AUDIBLE AND VISUAL ALARM, AND OPEN THE SAFETY AND EXHALATION VALVES WHICH ALLOWS THE PATIENT TO BREATHE THROUGH THE SYSTEM. WHEN THE SAFETY VALVE IS OPEN, THE VENTILATOR IS NOT PROVIDING BREATH SUPPORT TO THE PATIENT. IT IS ACCOMPANIED BY AN ALARM AND A SAFETY VALVE OPEN MESSAGE IN THE DISPLAY. THE VENTILATOR AUTOMATICALLY RESETS THE ALARM AND OPERATION OF THE VENTILATOR WHEN THE FLOW SENSOR LINE IS RECONNECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLV CONTINUUM II VENTILATOR VENTILATOR, CONTINUOUS CBK RESPIRONICS CALIFORNIA, INC. P2000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1