BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY 100

    MDR report key: 2871986 · Received December 11, 2012

    Report

    Report Number
    2518422-2012-02430
    Event Type
    Malfunction
    Date Received
    December 11, 2012
    Date of Event
    November 29, 2012
    Report Date
    November 28, 2012
    Manufacturer
    RESPIRONICS INC.
    Product Code
    CBK
    PMA / PMN Number
    K083526
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN RECEIVED BY THE MANUFACTURER, THE DEVICE HAD EVIDENCE OF THE ENCLOSURE BEING OPENED. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, THE LCD DISPLAY SCREEN CABLE WAS FOUND TO BE DISCONNECTED FROM THE SYSTEM BOARD. THE VENTILATOR'S LCD DISPLAY SCREEN CABLE WAS REATTACHED TO ADDRESS THIS ISSUE.

    Description of Event or Problem · 1

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING A "SERVICE REQUIRED" ALARM CONDITION OCCURRED. THERE WAS NO HARM OR INJURY REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1