BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 3953446 · Received July 23, 2014

    Report

    Report Number
    2031642-2014-00719
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Report Date
    June 26, 2014
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    MNT
    PMA / PMN Number
    K082660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    AFTER PREVENTIVE MAINTENANCE SERVICE OF THE DEVICE, THE MANUFACTURERS SERVICE ENGINEER REPORTED REVIEW OF THE DEVICE DIAGNOSTIC HISTORY INCLUDED CODES THAT INDICATED A SPI BUS FAILURE. THE SPI BUS IS COMMUNICATION USED TO READ DATA FOR PRESSURE AND FLOW SENSORS. THIS FAILURE MAY RESULT IN A VENT INOP OCCURRENCE DURING NORMAL VENTILATION OPERATION. A VENT INOP DURING NORMAL VENTILATION 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. THE SERVICE ENGINEER REPLACED THE DATA ACQUISTION PCB TO MOTOR CONTROLLER PCB CABLE TO ADDRESS THE FINDING. FINAL CHECK WAS COMPLETED WITH NO FAULT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430189 V60 VENTILATOR VENTILATOR, CONTINUOUS MNT RESPIRONICS CALIFORNIA, INC. V60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1