BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY O2

    MDR report key: 4851162 · Received June 17, 2015

    Report

    Report Number
    2518422-2015-01714
    Event Type
    Malfunction
    Date Received
    June 17, 2015
    Date of Event
    May 25, 2015
    Report Date
    May 25, 2015
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    CBK
    PMA / PMN Number
    K093905
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    SERVICE AND TESTING PERSONNEL

    Narratives

    Description of Event or Problem · 1

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR BEGAN OPERATING WITHOUT KEYPRESS ACTIVATION WHEN THE DEVICE WAS CONNECTED TO AC POWER. THE DEVICE WAS NOT IN PATIENT USE. THE VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR EVALUATION AND THE CUSTOMER'S COMPLAINT WAS CONFIRMED. THE DEVICE'S SYSTEM BOARD WAS REPLACED TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    393609 TRILOGY O2 VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS, INC. 1040004

    Patients

    Seq Age Sex Outcome Treatment
    1