BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY 200 VENTILATOR, CANADA - BT

    MDR report key: 23871872 · Received December 22, 2025

    Report

    Report Number
    2518422-2025-112979
    Event Type
    Malfunction
    Date Received
    December 22, 2025
    Date of Event
    December 17, 2025
    Report Date
    December 22, 2025
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    CBK
    UDI-DI
    00606959026452
    PMA / PMN Number
    K093416
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    A TRILOGY 200 VENTILATOR, CANADA - BT WAS RETURNED TO THE MANUFACTURER FOR ROUTINE PREVENTATIVE MAINTENANCE. THERE WAS NO ALLEGATION OF PATIENT HARM. THE DEVICE WAS NOT REPORTED TO BE IN PATIENT USE. THE TRILOGY 200 VENTILATOR, CANADA - BT DEVICE FAILED A DP PURGE VALVES TEST STEP DURING EVALUATION AT THE MANUFACTURER'S SERVICE CENTER. THE TECHNICIAN RECOMMENDED REPLACING THE DEVICE'S SENSOR BOARD TO ADDRESS THE ISSUE. THE REPAIR EVALUATION IS AWAITING CUSTOMER APPROVAL. A FINAL REPORT IS BEING SUBMITTED. IF NEW INFORMATION BECOMES AVAILABLE FOLLOWING THE COMPLETION OF THE DEVICE REPAIR THAT CHANGES THE OUTCOME OF THE INVESTIGATION AND ASSOCIATED MEDICAL DEVICE REPORTING A FOLLOW UP/SUPPLEMENTAL REPORT WILL BE COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1786259 TRILOGY 200 VENTILATOR, CANADA - BT VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS, INC. CA1032800B 00606959026452

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown