BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY 100

    MDR report key: 3880786 · Received April 9, 2014

    Report

    Report Number
    2518422-2014-00576
    Event Type
    Malfunction
    Date Received
    April 9, 2014
    Date of Event
    March 17, 2014
    Report Date
    March 17, 2014
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    CBK
    PMA / PMN Number
    K0835326
    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, A "VENTILATOR INOPERATIVE" CODE WAS FOUND IN THE VENTILATOR'S DOWNLOADED ERROR LOG. THE DEVICE'S BLOWER MOTOR AND SYSTEM BOARD WILL BE REPLACED TO ADDRESS THE ISSUE. OTHER - DEVICE HAS BEEN EVALUATED BUT THE COMPONENTS HAVE NOT BEEN REPLACED PENDING CUSTOMER APPROVAL OF THE ESTIMATE.

    Description of Event or Problem · 1

    A VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR ROUTINE PREVENTIVE MAINTENANCE. THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION. THE DEVICE WAS NOT IN PT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214025 TRILOGY 100 VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS, INC. 1054260

    Patients

    Seq Age Sex Outcome Treatment
    1