BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY 100

    MDR report key: 3813569 · Received March 26, 2014

    Report

    Report Number
    2518422-2014-00482
    Event Type
    Malfunction
    Date Received
    March 26, 2014
    Date of Event
    February 27, 2014
    Report Date
    February 27, 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

    Description of Event or Problem · 1

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING A "SERVICE REQUIRED" ALARM CONDITION OCCURRED. THE DEVICE WAS NOT IN PATIENT USE. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, "SERVICE REQUIRED" CODES WERE OBSERVED IN THE VENTILATOR'S DOWNLOADED ERROR LOG. THE DEVICE'S SYSTEM BOARD AND POWER MANAGEMENT BOARD WERE REPLACED TO ADDRESS THE ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    179003 TRILOGY 100 VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS INC. 1054260

    Patients

    Seq Age Sex Outcome Treatment
    1