BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY 100

    MDR report key: 2850092 · Received November 21, 2012

    Report

    Report Number
    2518422-2012-02268
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Date of Event
    October 29, 2012
    Report Date
    October 29, 2012
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    CBK
    PMA / PMN Number
    K083526
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DURING THE EVAL OF THE DEVICE AT THE MFR'S SVC CTR, AN ISSUE RELATED TO THE ACTIVE EXHALATION CONTROL MODULE WAS OBSERVED. THE DEVICE'S ACTIVE EXHALATION CONTROL MODULE WAS REPLACED TO ADDRESS THE ISSUE.

    Description of Event or Problem · 1

    A VENTILATOR WAS RETURNED TO THE MFR FOR SVC. THERE WAS NO HARM OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRILOGY 100 VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS, INC. 1054097

    Patients

    Seq Age Sex Outcome Treatment
    1