BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY EV300, USA

    MDR report key: 23114732 · Received September 22, 2025

    Report

    Report Number
    2518422-2025-110418
    Event Type
    Malfunction
    Date Received
    September 22, 2025
    Date of Event
    September 8, 2025
    Report Date
    September 22, 2025
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    CBK
    PMA / PMN Number
    K181166
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING A TRILOGY EV300 VENTILATOR FAILED ACTIVE EXHALATION CONTROL MODULE (AECM) TESTING. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF THE OCCURRENCE. THE TRILOGY EV300 VENTILATOR REQUIRES REPLACEMENT OF THE AECM PROPORTIONAL AND 3-WAY SOLENOID VALVES TO ADDRESS THE ISSUE. DEVICE REPAIR HAS NOT YET BEEN COMPLETED. ON-SITE DEVICE REPAIR BY PHILIPS SERVICE ENGINEER IS PLANNED AND SCHEDULED. THE ROOT CAUSE HAS NOT BEEN CONFIRMED AT THIS TIME. 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
    2511242 TRILOGY EV300, USA VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS, INC. DS2200X11B

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown