BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 3961547 · Received July 28, 2014

    Report

    Report Number
    2031642-2014-00748
    Event Type
    Malfunction
    Date Received
    July 28, 2014
    Report Date
    June 29, 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

    THE MANUFACTURERS SERVICE TECHNICIAN REPLACED THE DATA ACQUISITION PCB TO MOTOR CONTROLLER PCB CABLE TO ADDRESS THE REPORTED PROBLEM. FINAL CHECK WAS PERFORMED AND NO FAULT RECURRENCE WAS REPORTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE STOPPED FUNCTIONING. THE CUSTOMER REPORTED THE UNIT WAS NOT IN USE ON PATIENT; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT OR HARM. REVIEW OF THE DIAGNOSTIC LOG NOTED 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. 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 REPAIR IS HAS NOT BEEN COMPLETED PENDING CUSTOMER APPROVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437941 V60 VENTILATOR VENTILATOR, CONTINUOUS MNT RESPIRONICS CALIFORNIA, INC. V60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1