BEUDAMED
    FDA Adverse Event Summary report: N

    TRILOGY 100

    MDR report key: 2890932 · Received December 26, 2012

    Report

    Report Number
    2518422-2012-02505
    Date Received
    December 26, 2012
    Date of Event
    December 11, 2012
    Report Date
    December 11, 2012
    Manufacturer
    RESPIRONICS INC.
    Product Code
    CBK
    PMA / PMN Number
    K083526
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, A FAILURE RELATED TO THE REMOTE ALARM CONNECTOR WAS OBSERVED. THE DEVICE'S INTERFACE BOARD WAS REPLACED TO ADDRESS THE ISSUE.

    Description of Event or Problem · 1

    A VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR SERVICE EVALUATION. THE DEVICE WAS NOT IN PT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRILOGY 100 VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS INC. 1054097 1054097

    Patients

    Seq Age Sex Outcome Treatment
    1