BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY 200

    MDR report key: 3904855 · Received May 28, 2014

    Report

    Report Number
    2518422-2014-00853
    Event Type
    Malfunction
    Date Received
    May 28, 2014
    Date of Event
    April 29, 2014
    Report Date
    April 29, 2014
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    CBK
    PMA / PMN Number
    K093416
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR WAS NOT DELIVERING THE SET TIDAL VOLUME. THE DEVICE WAS NOT IN PATIENT USE. THE DEVICE HAS NOT YET BEEN EVALUATED BY THE MANUFACTURER. AT THIS TIME, WE ARE UNABLE TO CONFIRM THE ALLEGED MALFUNCTION. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315101 TRILOGY 200 VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS, INC. 1032804

    Patients

    Seq Age Sex Outcome Treatment
    1