BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 3241362 · Received July 22, 2013

    Report

    Report Number
    2031642-2013-00355
    Event Type
    Malfunction
    Date Received
    July 22, 2013
    Report Date
    July 10, 2013
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    MNT
    PMA / PMN Number
    K082660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: GAS DELIVERY SYSTEM.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE VENTILATOR WAS ALARMING DUE TO A LOW LEAK OCCURRENCE. THE CUSTOMER REPORTED THE DEVICE WAS IN USE ON A PATIENT AND THERE WAS NO PATIENT HARM. THE MANUFACTURERS FIELD SERVICE ENGINEER WAS ABLE TO DUPLICATE THE REPORTED PROBLEM. A LOW LEAK OCCURRENCE MAY POSE A CO2 REBREATHING RISK TO THE PATIENT WITH VENTILATION CONTINUING IF POSSIBLE. UPON EVALUATION, THE SERVICE ENGINEER REPORTED NO OCCLUSION IN THE EXHALATION PORT. THE SERVICE ENGINEER REPLACED THE GAS DELIVERY SYSTEM TO ADDRESS THE FINDING. PERFORMANCE VERIFICATION TESTING WAS COMPLETED AND PASSED TO SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340854 V60 VENTILATOR VENTILATOR, CONTINUOUS MNT RESPIRONICS CALIFORNIA, INC. V60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1