BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY 200

    MDR report key: 2883123 · Received December 18, 2012

    Report

    Report Number
    2518422-2012-02483
    Event Type
    Malfunction
    Date Received
    December 18, 2012
    Date of Event
    November 27, 2012
    Report Date
    November 27, 2012
    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

    Additional Manufacturer Narrative · 1

    DURING THE EVAL OF THE DEVICE AT THE MFR'S SERVICE CENTER, THE CUSTOMER'S COMPLAINT WAS CONFIRMED. THE FLOW SENSOR ASSEMBLY WAS FOUND TO HAVE CONTAMINATION (DUST). THE CONTAMINATION WAS REMOVED TO ADDRESS THIS ISSUE.

    Description of Event or Problem · 1

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

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1