BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY 100

    MDR report key: 2941128 · Received January 16, 2013

    Report

    Report Number
    2518422-2013-00059
    Event Type
    Malfunction
    Date Received
    January 16, 2013
    Date of Event
    December 26, 2012
    Report Date
    December 26, 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

    DURING THE EVAL OF THE DEVICE AT THE MFR'S SERVICE CENTER, SEVERAL "SERVICE REQUIRED" CODES WERE FOUND ON THE VENTILATOR'S DOWNLOADED ERROR LOG. THE DEVICE'S SENSOR BOARD AND POWER MANAGEMENT BOARD NEED TO BE REPLACED TO ADDRESS THE ISSUES. THE ESTIMATE FOR REPAIR WAS REJECTED BY THE CUSTOMER AND THE DEVICE WAS RETURNED UNREPAIRED PER THE CUSTOMER'S REQUEST. DEVICE RETURNED UNREPAIRED PER THE CUSTOMER'S REQUEST.

    Description of Event or Problem · 1

    A VENTILATOR WAS RETURNED TO THE MFR FOR ROUTINE PREVENTIVE MAINTENANCE. THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION. THERE WAS NO HARM OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    24977 TRILOGY 100 VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS INC. 1054260

    Patients

    Seq Age Sex Outcome Treatment
    1