BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY100

    MDR report key: 23240744 · Received October 7, 2025

    Report

    Report Number
    2518422-2025-049515
    Event Type
    Malfunction
    Date Received
    October 7, 2025
    Date of Event
    August 25, 2025
    Report Date
    May 22, 2026
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    CBK
    PMA / PMN Number
    K083526
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ON PREVIOUSLY SUBMITTED REPORT, 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 DURING TESTING FOR LOW OXYGEN FLOW. THE DEVICE'S INLET AIR PATH, AIR PATH FOAM, AND FLOW PATH WERE REPLACED TO ADDRESS THE ISSUE. THE DEVICE PASSED ALL TESTING. ADDITIONALLY, AFTER RE-EVALUATION, IT WAS DETERMINED THAT THE TEST FAIL WAS INCORRECTLY MENTIONED. BASED ON THE INFORMATION AVAILABLE AT THIS TIME OF INVESTIGATION, IT HAS BEEN DETERMINED THAT THERE IS NO EVIDENCE THAT THE DEVICE MALFUNCTIONED IN A MANNER THAT WOULD BE LIKELY TO CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY IF IT WERE TO RECUR. THERE WAS NO SERIOUS PATIENT HARM OR INJURY ASSOCIATED WITH THIS DEVICE AND NO INCREASED RISK TO THE INTENDED USER. BASED ON THE INFORMATION AVAILABLE, IT IS A NON-REPORTABLE COMPLAINT.

    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 DURING TESTING FOR LOW OXYGEN 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
    523794 TRILOGY100 VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS, INC. 1054260

    Patients

    Seq Age Sex Outcome Treatment
    1