BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 3833928 · Received May 27, 2014

    Report

    Report Number
    2031642-2014-00399
    Event Type
    Malfunction
    Date Received
    May 27, 2014
    Report Date
    May 1, 2014
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    MNT
    PMA / PMN Number
    K082660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    FLOW SENSOR.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE VENTILATOR FAILED ON POWER UP DURING INITIAL USE OF THE VENTILATOR. THE DEVICE WAS NOT IN USE ON A PATIENT THEREFORE THERE WAS NO PATIENT INVOLVEMENT OR HARM. THE VENTILATOR WAS RETURNED TO THE MANUFACTURER. FACTORY EVALUATION AND TESTING REVEALED THE VENTILATOR WOULD NOT POWER UP. THE REPORTED PROBLEM WAS TRACED TO AN INTERNAL OPEN ON A INTEGRATED CIRCUIT COMPONENT OF THE OXYGEN FLOW SENSOR. THE NOTED FAILURE MAY RESULT IN A SHUTDOWN OF THE DEVICE DURING USE IN NORMAL VENTILATION OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310942 V60 VENTILATOR VENTILATOR, CONTINUOUS MNT RESPIRONICS CALIFORNIA, INC. V60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1