BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY EV300, USA

    MDR report key: 22610139 · Received July 25, 2025

    Report

    Report Number
    2518422-2025-108265
    Event Type
    Malfunction
    Date Received
    July 25, 2025
    Date of Event
    July 17, 2025
    Report Date
    January 12, 2026
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    CBK
    UDI-DI
    00606959052017
    PMA / PMN Number
    K181166
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER PREVIOUSLY REPORTED OF A VENTILATOR THAT WAS RETURNED TO THE MANUFACTURER FOR ROUTINE PREVENTATIVE MAINTENANCE. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE WAS NOT REPORTED TO BE IN PATIENT USE. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, THE DEVICE FAILED THE SYSTEM SETUP TEST DURING TESTING. THE TECHNICIAN RECOMMENDED REPLACING THE DEVICE'S ACTIVE EXHALATION CONTROL MODULE AND 3-WAY SOLENOID VALVES TO ADDRESS THE ISSUE. NO FURTHER INVESTIGATION IS REQUIRED 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. THE DEVICE'S PROPORTIONAL VALVE (AECM) WAS RETURNED TO THE MANUFACTURER'S PRODUCT INVESTIGATION LABORATORY (PIL). PIL WAS UNABLE TO CONFIRM A FAILURE OF THE PROPORTIONAL VALVE. PIL TESTED THE PROPORTIONAL VALVE ON THE PIL TRILOGY EVO MULTIFUNCTIONAL TEST STATION FOR AECM VERIFICATION AT PRE TEST AND AECM VERIFICATION AT POST TEST AND THE PROPORTIONAL VALVE PASSED ALL TESTING. PIL CONCLUDED THAT THE PROPORTIONAL VALVE OPERATES AS DESIGNED.

    Description of Event or Problem · 0

    A VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR ROUTINE PREVENTATIVE MAINTENANCE. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE WAS NOT REPORTED TO BE IN PATIENT USE. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, THE DEVICE FAILED THE SYSTEM SETUP TEST DURING TESTING. THE TECHNICIAN RECOMMENDED REPLACING THE DEVICE'S ACTIVE EXHALATION CONTROL MODULE AND 3-WAY SOLENOID VALVES TO ADDRESS THE ISSUE. NO FURTHER INVESTIGATION IS REQUIRED 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
    2382883 TRILOGY EV300, USA VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS, INC. DS2200X11B 00606959052017

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown