BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 3820161 · Received April 4, 2014

    Report

    Report Number
    2031642-2014-00235
    Event Type
    Malfunction
    Date Received
    April 4, 2014
    Report Date
    March 13, 2014
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    MNT
    PMA / PMN Number
    K082660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    OXYGEN CYLINDER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE VENTILATOR ALARMED WITH A MESSAGE INDICATING HIGH OXYGEN SUPPLY PRESSURE. THE CUSTOMER REPORTED THERE WAS NO PT HARM. WHEN THE MEASURED OXYGEN INLET PRESSURE IS GREATER THAN 92 PSI, THE HIGH OXYGEN SUPPLY PRESSURE ALARM IS ACTIVE, THE OXYGEN VALE IS CLOSED AND O2 ENRICHMENT ENDS. THE VENTILATOR CONTINUES TO PROVIDE VENTILATORY SUPPORT TO THE PT USING AN AIR GAS SOURCE UNTIL THE PRESSURE FALLS TO A SPECIFIED LEVEL AND THE OXYGEN VALVE OPENS. LOSS OF THE OXYGEN SOURCE CAN BE DETRIMENTAL TO A PT. THE FSE INFORMED THE CUSTOMER THAT THE O2 CYLINDER IS THE CAUSED OF THE REPORTED PROBLEM. THE RT DIRECTOR ORDERED THE REMOVAL OF THE O2 CYLINDER AND NOT ALLOWING ANYONE TO USE THESE CYLINDERS WITH THE V60. FSE ALSO TESTED THE UNIT AND VERIFIED THAT IS FUNCTIONING CORRECTLY. ALL APPLICABLE TESTING WAS PERFORMED AND PASSED. SEE SCANNED PAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204678 V60 VENTILATOR VENTILATOR, CONTINUOUS MNT RESPIRONICS CALIFORNIA, INC. V30 NA

    Patients

    Seq Age Sex Outcome Treatment
    1