BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY 100 VENTILATOR, U.S.A - BT

    MDR report key: 24027213 · Received January 9, 2026

    Report

    Report Number
    2518422-2026-001543
    Event Type
    Malfunction
    Date Received
    January 9, 2026
    Date of Event
    December 22, 2025
    Report Date
    January 9, 2026
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    CBK
    UDI-DI
    00606959026353
    PMA / PMN Number
    K083526
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    A TRILOGY 100 VENTILATOR, U.S.A - BT WAS RETURNED TO THE MANUFACTURER FOR ROUTINE PREVENTATIVE MAINTENANCE. THERE WAS NO ALLEGATION OF HARM OR INJURY REPORTED. THE DEVICE WAS NOT REPORTED TO BE IN PATIENT USE. THE TRILOGY 100 VENTILATOR, U.S.A - BT DEVICE FAILED A 02 LOW FLOW TEST STEP DURING EVALUATION AT THE MANUFACTURER'S SERVICE CENTER. THE TECHNICIAN RECOMMENDED REPLACING THE DEVICE'S ACTIVE EXHALATION CONTROL MODULE (ACTIVE EXHALATION CONTROLLER) TO ADDRESS THE ISSUE. ADDITIONALLY, THE DEVICE'S CABLE CLAMP WAS REPLACED SINCE THE CORD RETAINER MISSING OR BROKEN. THE FRONT AND BASE ENCLOSURE ASSEMBLIES HAVE BEEN REPLACED DUE TO HAVING BEEN DAMAGED. 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
    92570 TRILOGY 100 VENTILATOR, U.S.A - BT VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS, INC. U1054260B 00606959026353

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown