BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 3910201 · Received July 2, 2014

    Report

    Report Number
    2031642-2014-00598
    Event Type
    Malfunction
    Date Received
    July 2, 2014
    Report Date
    June 6, 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

    DURING TESTING OF THE DEVICE POST-SERVICE, THE MANUFACTURERS SERVICE ENGINEER REPORTED A VENT INOP OCCURRENCE DUE TO A DATA ACQUISITION PCBA ADC REFERENCE FAILURE. VENT INOP IS A HIGH PRIORITY CONDITION THAT PRECLUDES SAFE OPERATION OF THE VENTILATOR IN NORMAL VENTILATION MODE. A VENT INOP ALARM DISPLAYS ON THE SCREEN, TURNS ON REMOTE ALARM INTERFACES, AND DISABLES OXYGEN FLOW AND BLOWER OPERATION. IF IN USE, THE PATIENT MUST BE PLACED ON ANOTHER MEANS OF VENTILATORY SUPPORT. THE SERVICE ENGINEER REPLACED THE DATA ACQUISITION PCB TO MOTOR CONTROLLER PCB CABLE TO ADDRESS THE REPORTED PROBLEM. FINAL TESTING WAS COMPLETED PER OPERATING SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387375 V60 VENTILATOR VENTILATOR, CONTINUOUS MNT RESPIRONICS CALIFORNIA, INC. V60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1