BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 2882576 · Received December 20, 2012

    Report

    Report Number
    2031642-2012-00552
    Event Type
    Malfunction
    Date Received
    December 20, 2012
    Report Date
    December 10, 2012
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    MNT
    PMA / PMN Number
    K082660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    GAS DELIVERY SYSTEM.

    Description of Event or Problem · 1

    DURING SERVICE OF THE VENTILATOR, REVIEW OF THE DEVICE DIAGNOSTIC LOG NOTED VENT INOP OCCURRENCES DUE TO PRESSURE AUTOZEROING AND HIGH PRESSURE REGULATION AND 35VOLT FAILURE OCCURRENCE. THERE WAS NO REPORT OF THE OCCURRENCES DURING USE ON A PATIENT. THE CUSTOMER REPORTED TO THE MANUFACTURER'S SERVICE TECHNICIAN THAT THE VENTILATOR WAS ALARMING ON STARTUP DUE TO PRESSURE SENSORS FAILED. THE SERVICE TECHNICIAN REPLACED THE CPU BOARD TO ADDRESS THE FINDINGS. PERFORMANCE VERIFICATION TESTING WAS COMPLETED AND PASSED TO OPERATING SPECIFICATIONS. A VENT INOP CONDITION DURING OPERATION WILL RESULT IN A VISUAL AND AUDIBLE ALARM AND PRECLUDES CONTINUED SAFE OPERATION OF THE VENTILATOR. THE USER MUST PROVIDE ALTERNATIVE VENTILATION AND HAVE THE VENTILATOR SERVICED.

    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