BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY 100

    MDR report key: 4092809 · Received August 20, 2014

    Report

    Report Number
    2518422-2014-01406
    Event Type
    Malfunction
    Date Received
    August 20, 2014
    Date of Event
    July 23, 2014
    Report Date
    July 23, 2014
    Manufacturer
    RESPIRONICS INC.
    Product Code
    CBK
    PMA / PMN Number
    K083526
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DURING EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, "VENTILATOR INOPERATIVE" CODES WERE OBSERVED IN THE VENTILATOR'S DOWNLOADED ERROR LOG. THE DEVICE'S SOFTWARE WAS RELOADED TO ADDRESS THE ISSUE. THE REPAIR OF THE DEVICE IS STILL IN PROGRESS, 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 PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    500683 TRILOGY 100 VENTILATOR, CONINUOUS, FACILITY USE CBK RESPIRONICS INC. 1054260

    Patients

    Seq Age Sex Outcome Treatment
    1