BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY 100 VENTILATOR, U.S.A - BT

    MDR report key: 24650944 · Received March 20, 2026

    Report

    Report Number
    2518422-2026-009821
    Event Type
    Malfunction
    Date Received
    March 20, 2026
    Date of Event
    February 23, 2026
    Report Date
    March 20, 2026
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    CBK
    UDI-DI
    00606959026353
    PMA / PMN Number
    K083526
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 PATIENT HARM. THE DEVICE WAS NOT REPORTED TO BE IN PATIENT USE. DURING THE EVALUATION AT THE MANUFACTURER'S SERVICE CENTER, THE TRILOGY 100 VENTILATOR, U.S.A - BT DEVICE FAILED A PRESSURE SENSORS CALIBRATION. THE DEVICE'S SENSOR BOARD WAS REPLACED TO ADDRESS THE TEST FAILURE. THE DEVICE PASSED ALL TESTING. ADDITIONALLY, THE FRONT CASE ENCLOSURE WAS REPLACED DUE TO SCRATCHES ON THE SCREEN AND WILL BE RETESTED. 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
    712553 TRILOGY 100 VENTILATOR, U.S.A - BT VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS, INC. 1054260B 00606959026353

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown