BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY

    MDR report key: 23084670 · Received September 18, 2025

    Report

    Report Number
    2518422-2025-110346
    Event Type
    Malfunction
    Date Received
    September 18, 2025
    Date of Event
    September 3, 2025
    Report Date
    September 18, 2025
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    CBK
    UDI-DI
    00606959015364
    PMA / PMN Number
    K083526
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 TEST STEP, AND IT PASSED ON THE DEVICE. ADDITIONAL FINDINGS NOT RELATED TO THE MALFUNCTION/ISSUE WAS THE RUBBER FEET MISSING. THE PHILIPS SERVICE TECHNICIAN REPLACED THE DEVICE'S ENCLOSURE RUBBER FEET THIS ISSUE. THE PHILIPS SERVICE TECHNICIAN WAS NOT ABLE TO CONFIRM THE GAP BETWEEN ENCLOSURES ON THIS DEVICE. THERE WERE NO REPAIR(S) OR PART(S) REPLACED WERE PERFORMED FOR THE GAP BETWEEN ENCLOSURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2598826 TRILOGY VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS, INC. 1054260 140821 00606959015364

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown