BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 3230058 · Received July 16, 2013

    Report

    Report Number
    2031642-2013-00343
    Event Type
    Malfunction
    Date Received
    July 16, 2013
    Report Date
    July 3, 2013
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    MNT
    PMA / PMN Number
    K082660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    GAS DELIVERY SYSTEM.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE VENTILATOR WAS DISPLAYING A PRESSURE SENSOR FAILURE. THE CUSTOMER REPORTED THE DEVICE WAS NOT IN USE ON A PATIENT. THE MANUFACTURERS SERVICE ENGINEER WAS ABLE TO DUPLICATE THE REPORTED PROBLEM. REVIEW OF THE DEVICE DIAGNOSTIC LOG VERIFIED PROXIMAL AND MACHINE PRESSURE SENSOR AUTOZEROING FAILED. AS NOTED, IF THE REPORTED PROBLEM OCCURRED WHILE IN USE IN NORMAL VENTILATION MODE OPERATION IT MAY AFFECT THE ACCURACY OF THE SYSTEM PRESSURE MEASUREMENT AND MAY RESULT IN THE UNIT GOING VENT INOP. A VENT INOP ALARM DISPLAYS ON THE SCREEN, TURNS ON REMOTE ALARM INTERFACES, AND DISABLES OXYGEN FLOW AND BLOWER OPERATION. THE MANUFACTURERS SERVICE TECHNICIAN REPLACED THE GAS DELIVERY SYSTEM TO ADDRESS THE REPORTED PROBLEM. PERFORMANCE VERIFICATION TESTING WAS COMPLETED AND PASSED TO SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328716 V60 VENTILATOR VENTILATOR, CONTINUOUS MNT RESPIRONICS CALIFORNIA, INC. V60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1