BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 3834602 · Received February 14, 2014

    Report

    Report Number
    2031642-2014-00113
    Event Type
    Malfunction
    Date Received
    February 14, 2014
    Report Date
    January 22, 2014
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    MNT
    PMA / PMN Number
    K082660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE VENTILATOR WAS ALARMING DUE TO OXYGEN SUPPLY PRESSURE AND SENSOR RANGE ERRORS. THE CUSTOMER REPORTED THE VENTILATOR WAS NOT IN USE. THE MANUFACTURER'S FIELD SERVICE ENGINEER INSPECTED THE UNIT AND FOUND THAT THE CUSTOMER WAS USING AN INCORRECT O2 REGULATOR FOR THEIR E CYLINDER. PER THE DEVICE OPERATORS MANUAL, THE VENTILATOR SHOULD ONLY BE CONNECTED TO AN OXYGEN GAS SOURCE CAPABLE OF DELIVERING A REGULATED 40-90 PSIG. IF THE CUSTOMER'S REGULATOR DOES NOT DELIVER A REGULATED PSIG TO THE VENTILATOR AS SPECIFIED, IT MAY RESULT IN A HIGH OXYGEN SUPPLY PRESSURE ALARM WHICH MAY CLOSE THE OXYGEN VALVE. IF THE HIGH OXYGEN SUPPLY PRESSURE CLOSES THE OXYGEN VALVE, THE VENTILATOR CONTINUES TO VENTILATE WITH AIR ONLY. LOSS OF THE OXYGEN SOURCE CAN BE DETRIMENTAL TO THE PATIENT. THIS IS BEING REPORTED AS OPERATOR ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98021 V60 VENTILATOR MNT RESPIRONICS CALIFORNIA, INC. V60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1