BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY 100

    MDR report key: 24129709 · Received January 21, 2026

    Report

    Report Number
    2518422-2026-100178
    Event Type
    Malfunction
    Date Received
    January 21, 2026
    Date of Event
    January 14, 2026
    Report Date
    January 21, 2026
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    CBK
    UDI-DI
    00606959015364
    PMA / PMN Number
    K083526
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    A VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR SERVICE. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, THE DEVICE FAILED A TEST STEP FOR OXYGEN LOW FLOW. THE DEVICE'S INLET AIR PATH, AIR PATH FOAM, AND FLOW PATH WERE REPLACED TO ADDRESS THE ISSUE. THE DEVICE PASSED ALL TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196621 TRILOGY 100 VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS, INC. 1054260 00606959015364

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown