BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTIILATOR

    MDR report key: 4213362 · Received October 24, 2014

    Report

    Report Number
    2031642-2014-01294
    Event Type
    Malfunction
    Date Received
    October 24, 2014
    Report Date
    October 1, 2014
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    MNT
    PMA / PMN Number
    K082660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WERE NO SIGNS OF DAMAGE OR CONTAMINATION. THE GDS SYSTEM WAS ALLOWED TO RUN FOR 4 HOURS TO VERIFY THE UNIT REMAINS OPERATIONAL WITH NO ERRORS. NO ERRORS WERE GENERATED DURING APPROXIMATELY 4 HOURS OF OPERATION. THE GDS SYSTEM WAS TESTED AND NO FAILURES WERE IDENTIFIED.

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE VENTILATOR WAS ALARMING DUE TO PRESSURE SENSORS FAILURE. THE CUSTOMER REPORTED THE DEVICE WAS NOT IN USE ON A PT. AS REPORTED, IF THE REPORTED PROBLEMS OCCURS WHILE IN USE IN NORMAL VENTILATION 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 MFR'S FIELD SERVICE ENGINEER (FSE) HAS NOT COMPLETED REPAIR ON THIS UNIT. THIS UNIT IS PENDING MORE TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    678061 V60 VENTIILATOR VENTILATOR, CONTINUOUS MNT RESPIRONICS CALIFORNIA, INC. V60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1