BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY 100

    MDR report key: 3172318 · Received June 5, 2013

    Report

    Report Number
    2518422-2013-01058
    Event Type
    Malfunction
    Date Received
    June 5, 2013
    Date of Event
    May 8, 2013
    Report Date
    May 8, 2013
    Manufacturer
    RESPIRONICS INC.
    Product Code
    CBK
    PMA / PMN Number
    K083526
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR REVIEWED THE ERROR CODES REPORTED BY THE THIRD PARTY SERVICE CENTER AND THE REPORTED VENTILATOR INOPERATIVE CONDITION WAS NOT CONFIRMED. THE VENTILATOR ERROR CODES REPORTED BY THE THIRD PARTY WERE SERVICE REQUIRED CODES NOT VENTILATOR INOPERATIVE CODES. THE DEVICE'S POWER MANAGEMENT BOARD AND THE CABLE BETWEEN THE SYSTEM BOARD AND SENSOR BOARD WERE REPLACED TO ADDRESS THE ISSUE.

    Description of Event or Problem · 1

    THE MFR RECEIVED INFO FROM A THIRD PARTY SERVICE CENTER ALLEGING A VENTILATOR INOPERATIVE CONDITION OCCURRED. THERE WAS NO HARM OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249465 TRILOGY 100 VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS INC. 1054096

    Patients

    Seq Age Sex Outcome Treatment
    1