BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY 100

    MDR report key: 3061045 · Received April 9, 2013

    Report

    Report Number
    2518422-2013-00555
    Event Type
    Malfunction
    Date Received
    April 9, 2013
    Date of Event
    March 21, 2013
    Report Date
    March 21, 2013
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    CBK
    PMA / PMN Number
    K083526
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DURING THE EVAL OF THE DEVICE AT THE MFR'S SERVICE CENTER, "SERVICE REQUIRED" CODES WERE FOUND IN THE VENTILATOR'S DOWNLOADED ERROR LOG. THE DEVICE'S SENSOR BOARD, POWER MANAGEMENT BOARD AND INTERNAL BATTERY WILL BE REPLACED TO ADDRESS THE ISSUES. DEVICE HAS BEEN EVALUATED, BUT THE COMPONENTS HAVE NOT BEEN REPLACED PENDING CUSTOMER APPROVAL OF ESTIMATE.

    Description of Event or Problem · 1

    A VENTILATOR WAS RETURNED TO THE MFR FOR SERVICE. THERE WAS NO HARM OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148001 TRILOGY 100 VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS, INC. 1054096

    Patients

    Seq Age Sex Outcome Treatment
    1