BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY EV300, USA

    MDR report key: 23095464 · Received September 19, 2025

    Report

    Report Number
    2518422-2025-110383
    Event Type
    Malfunction
    Date Received
    September 19, 2025
    Date of Event
    September 5, 2025
    Report Date
    September 19, 2025
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    CBK
    UDI-DI
    00606959052017
    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 AS PART OF PRE-CHECK TESTING. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF THE OCCURRENCE. NO HARM OR INJURY WAS REPORTED. PHILIPS SERVICE DETERMINED THE AECM TEST FAILURE REQUIRED REPLACEMENT OF THE 3-WAY SOLENOID AND PROPORTIONAL VALVES TO ADDRESS THE ISSUE. DEVICE REPAIR HAS NOT YET BEEN COMPLETED. A FINAL REPORT IS BEING SUBMITTED. IF NEW OR ADDITIONAL INFORMATION BECOMES AVAILABLE FOLLOWING THE COMPLETION OF THE DEVICE REPAIR THAT CHANGES THE OUTCOME OF THE INVESTIGATION AND ASSOCIATED MEDICAL DEVICE REPORTING, FOLLOW UP/SUPPLEMENTAL REPORTING WILL BE COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1722180 TRILOGY EV300, USA VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS, INC. DS2200X11B 00606959052017

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown