BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY

    MDR report key: 23139280 · Received September 24, 2025

    Report

    Report Number
    2518422-2025-110485
    Event Type
    Malfunction
    Date Received
    September 24, 2025
    Date of Event
    August 12, 2025
    Report Date
    September 24, 2025
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    CBK
    PMA / PMN Number
    K083526
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED INFORMATION FROM A PHILIPS SERVICE TECHNICIAN THAT THE LOW FLOW OXYGEN (O2) TEST STEP HAD FAILED ON THE TRILOGY 100 DEVICE. THERE WAS NO SERIOUS PATIENT HARM OR INJURY THAT OCCURRED OR WAS REPORTED. THE PHILIPS SERVICE TECHNICIAN EVALUATED AND DETERMINED THE INLET AIR PATH, AIR PATH FOAM, AND FLOW PATH TUBING HAD CAUSED THE LOW FLOW O2 TEST STEP TO FAIL ON THE DEVICE. THE PHILIPS SERVICE TECHNICIAN REPLACED THE DEVICE'S INLET AIR PATH, AIR PATH FOAM, AND FLOW PATH TUBING TO ADDRESS THIS ISSUE ON THE DEVICE. THE PHILIPS SERVICE TECHNICIAN RE-PERFORMED THE TESTING ON THE DEVICE, AND ALL TESTING ON THE DEVICE HAD PASSED. ADDITIONALLY, DURING THE SERVICE OF THE DEVICE, THE RUBBER FEET WAS REPLACED FOR EITHER MISSING OR DISPLACED AND IS UNRELATED TO THE REPORTABLE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2395082 TRILOGY VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS, INC. 1054260 110805

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown