BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY 100

    MDR report key: 3913330 · Received May 14, 2014

    Report

    Report Number
    2518422-2014-00782
    Event Type
    Malfunction
    Date Received
    May 14, 2014
    Date of Event
    April 22, 2014
    Report Date
    April 22, 2014
    Manufacturer
    RESPIRONICS INC.
    Product Code
    CBK
    PMA / PMN Number
    K083526
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DURING THE EVAL OF THE DEVICE AT THE MFR'S SERVICE CENTER, THE DEVICE FAILED A STEP DURING TESTING. THE DEVICE'S FLOW SENSOR ASSEMBLY WAS FOUND TO BE CONTAMINATED WITH DUST. THE DEVICE'S FLOW SENSOR ASSEMBLY WAS REPLACED TO ADDRESS THE ISSUE.

    Description of Event or Problem · 1

    THE MFR RECEIVED INFO ALLEGING A VENTILATOR WAS ALARMING. THERE WAS NO HARM OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288218 TRILOGY 100 VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS INC. 1054096

    Patients

    Seq Age Sex Outcome Treatment
    1