BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY 200

    MDR report key: 2854562 · Received November 29, 2012

    Report

    Report Number
    2518422-2012-02328
    Event Type
    Malfunction
    Date Received
    November 29, 2012
    Date of Event
    November 8, 2012
    Report Date
    November 8, 2012
    Manufacturer
    RESPIRONICS INC.
    Product Code
    CBK
    PMA / PMN Number
    K093416
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, THE DEVICE FAILED A STEP DURING TESTING. THE DEVICE'S BLOWER MOTOR WAS REPLACED TO ADDRESS THE ISSUE. A "SERVICE REQUIRED" CODE WAS FOUND IN THE VENTILATOR'S DOWNLOADED ERROR LOG. THE VENTILATOR'S SENSOR PCA AND SYSTEM PCA WERE REPLACED TO ADDRESS THIS ISSUE.

    Description of Event or Problem · 1

    A VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR SERVICE. 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. 1032800

    Patients

    Seq Age Sex Outcome Treatment
    1