BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 2071119 · Received April 27, 2011

    Report

    Report Number
    2031642-2011-00120
    Event Type
    Malfunction
    Date Received
    April 27, 2011
    Date of Event
    March 29, 2011
    Report Date
    March 29, 2011
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    MNT
    PMA / PMN Number
    K082660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE VENTILATOR WAS ALARMING WHILE IN USE ON A PATIENT DUE TO A LOSS OF OXYGEN. THE MANUFACTURER'S SERVICE TECHNICIAN WAS UNABLE TO DUPLICATE THE CUSTOMER REPORTED PROBLEM, HOWEVER REVIEW OF THE DIAGNOSTIC LOG HISTORY NOTED A HIGH OXYGEN SUPPLY PRESSURE ALARM OCCURRED AT THE TIME OF THE REPORTED O2 EVENT. WHEN THE MEASURED OXYGEN INLET PRESSURE IS GREATER THAN 92 PSI, THE HIGH OXYGEN SUPPLY PRESSURE ALARM IS ACTIVE, THE OXYGEN VALVE IS CLOSED AND O2 ENRICHMENT ENDS. THE VENTILATOR CONTINUES TO PROVIDE VENTILATORY SUPPORT TO THE PATIENT 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 PATIENT IF THIS TYPE OF EVENT OCCURS DURING USE. THE SERVICE TECHNICIAN WAS UNABLE TO DUPLICATE THE HIGH OXYGEN SUPPLY PRESSURE OCCURRENCE AND THE VENTILATOR PASSED OPERATIONAL TESTING. PER LABELING, THE OXYGEN SOURCE MUST BE ABLE TO DELIVER 100% OXYGEN REGULATED TO 40-87 PSI.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1