BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY 02

    MDR report key: 2872038 · Received December 11, 2012

    Report

    Report Number
    2518422-2012-02415
    Event Type
    Malfunction
    Date Received
    December 11, 2012
    Date of Event
    November 20, 2012
    Report Date
    November 20, 2012
    Manufacturer
    RESPIRONICS INC.
    Product Code
    CBK
    PMA / PMN Number
    K093905
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DURING THE EVAL OF THE DEVICE AT THE MFR¿S SERVICE CENTER, 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

    THE MFR RECEIVED INFO ALLEGING A VENTILATOR¿S EXPIRATORY VALVE WAS NOT OPERATING. THERE WAS NO HARM OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRILOGY 02 VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS INC. 1040004

    Patients

    Seq Age Sex Outcome Treatment
    1