BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY EV300, USA

    MDR report key: 21977869 · Received May 7, 2025

    Report

    Report Number
    2518422-2025-105301
    Event Type
    Malfunction
    Date Received
    May 7, 2025
    Date of Event
    April 22, 2025
    Report Date
    September 25, 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
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT INVESTIGATION LAB (PIL) A RECEIVED A TRILOGY EVO PROPORTIONAL VALVE WITH THE ALLEGATION OF FAILING ACTIVE EXHALATION CONTROL MODULE (AECM) VERIFICATION TEST. PIL INSTALLED THE TRILOGY EVO PROPORTIONAL VALVE ON THE TRILOGY EVO TEST BED 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. PIL CONCLUDED THAT THE PROPORTIONAL VALVE OPERATES AS DESIGNED. PIL RECEIVED A TRILOGY EVO SOLENOID VALVE WITH THE ALLEGATION OF FAILING AECM VERIFICATION TEST. 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 SOLENOID CURRENT VERIFICATION AT PRETEST AND AECM VERIFICATION AT POSTTEST AND PASSED TESTING AT POSTTEST, HOWEVER FAILED AECM VERIFICATION TESTING AT PRETEST. PIL SUSPECTS THAT INTERNAL CONTAMINATION CAUSED THE FAILURE OF THE SOLENOID VALVE.

    Description of Event or Problem · 0

    A TRILOGY EV300 VENTILATOR WAS REPORTED TO HAVE FAILED CALIBRATION DURING TESTING AT THE CUSTOMER SITE. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE FAILED A TEST STEP DURING TESTING. THE DEVICE'S 3-WAY SOLENOID VALVE AND PROPORTIONAL VALVE REQUIRE REPLACEMENT TO ADDRESS THE ISSUE. A PHILIPS FIELD SERVICE ENGINEER WILL COMPLETE THE REQUIRED REPAIRS AT THE CUSTOMER SITE. 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
    1513730 TRILOGY EV300, USA VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS, INC. DS2200X11B

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown