BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY 100

    MDR report key: 4113762 · Received September 17, 2014

    Report

    Report Number
    2518422-2014-01595
    Event Type
    Malfunction
    Date Received
    September 17, 2014
    Date of Event
    August 20, 2014
    Report Date
    August 20, 2014
    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, "VENTILATOR INOPERATIVE" CODES RELATED TO THE BLOWER MOTOR AND THE DEVICE REQUIRING A SOFTWARE RELOAD WERE OBSERVED IN THE VENTILATOR'S DOWNLOADED ERROR LOG. THE VENTILATOR FAILED A TEST STEP RELATED TO THE ACTIVE EXHALATION CONTROL MODULE DURING TESTING. CONCLUSIONS: THE ESTIMATE WAS REJECTED AND THE DEVICE WAS SCRAPED, PER THE CUSTOMER'S REQUEST.

    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
    575650 TRILOGY 100 VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS INC. 1054096

    Patients

    Seq Age Sex Outcome Treatment
    1