BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY EV300, USA

    MDR report key: 23794952 · Received December 12, 2025

    Report

    Report Number
    2518422-2025-112627
    Event Type
    Malfunction
    Date Received
    December 12, 2025
    Date of Event
    November 18, 2025
    Report Date
    March 23, 2026
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    CBK
    UDI-DI
    00606959052017
    PMA / PMN Number
    K181166
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER PREVIOUSLY REPORTED TO A TRILOGY EV300, USA VENTILATOR, WAS EVALUATED AS ROUTINE PREVENTATIVE MAINTENANCE. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE WAS NOT REPORTED TO BE IN PATIENT USE. DURING THE PRETESTING EVALUATION OF THE TRILOGY EV300, USA DEVICE BY A MANUFACTURER'S SERVICE CENTER, THE DEVICE FAILED SYSTEM SETUP TEST. REPLACING THE DEVICE'S ACTIVE EXHALATION CONTROL MODULE AND 3-WAY SOLENOID VALVES IS RECOMMENDED TO ADDRESS THE ISSUE. THE ONSITE SERVICE HAS BEEN SCHEDULED. 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 DEVICES 3-WAY SOLENOID VALVE AND ACTIVE EXHALATION CONTROL MODULE (AECM) WERE RETURNED TO THE MANUFACTURER'S PRODUCT INVESTIGATION LABORATORY (PIL) FOR FURTHER INVESTIGATION. THE TECHNICIAN AT THE PIL INSTALLED THE TRILOGY EVO SOLENOID VALVE ON THE TRILOGY EVO STB AND THEN TESTED THE SOLENOID VALVE ON THE PIL TRILOGY EVO MULTIFUNCTIONAL TEST STATION FOR AECM VERIFICATION AND AECM SOLENOID CURRENT VERIFICATION AT PRETEST AND AECM VERIFICATION AT POSTTEST AND PASSED TESTING AT POSTTEST, HOWEVER FAILED AECM VERIFICATION TESTING AT PRETEST. THE PIL SUSPECTS THAT INTERNAL CONTAMINATION CAUSED THE FAILURE OF THE SOLENOID VALVE. THE TECHNICIAN AT PIL INSTALLED THE TRILOGY EVO PROPORTIONAL VALVE ON THE TRILOGY EVO STB AND THEN TESTED THE PROPORTIONAL VALVE ON THE PIL TRILOGY EVO MULTIFUNCTIONAL TEST STATION FOR AECM VERIFICATION AT PRETEST AND AECM VERIFICATION AT POSTTEST AND PASSED ALL TESTING. THE PIL CONCLUDED THAT THE PROPORTIONAL VALVE OPERATES AS DESIGNED. THE TRILOGY EVO PROPORTIONAL VALVE AND 3-WAY SOLENOID VALVE HAVE BEEN SCRAPPED.

    Description of Event or Problem · 0

    A TRILOGY EV300, USA VENTILATOR, WAS EVALUATED AS ROUTINE PREVENTATIVE MAINTENANCE. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE WAS NOT REPORTED TO BE IN PATIENT USE. DURING THE PRETESTING EVALUATION OF THE TRILOGY EV300, USA DEVICE BY A MANUFACTURER'S SERVICE CENTER, THE DEVICE FAILED SYSTEM SETUP TEST. REPLACING THE DEVICE'S ACTIVE EXHALATION CONTROL MODULE AND 3-WAY SOLENOID VALVES IS RECOMMENDED TO ADDRESS THE ISSUE. THE ONSITE SERVICE HAS BEEN SCHEDULED. 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
    2770711 TRILOGY EV300, USA VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS, INC. DS2200X11B 00606959052017

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown