BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY EV300, USA

    MDR report key: 21960103 · Received May 5, 2025

    Report

    Report Number
    2518422-2025-105160
    Event Type
    Malfunction
    Date Received
    May 5, 2025
    Date of Event
    April 14, 2025
    Report Date
    September 25, 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
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT INVESTIGATION LAB (PIL) RECEIVED A TRILOGY EVO PROPORTIONAL VALVE WITH THE ALLEGATION OF PRODUCT FAILED SYSTEM PRETEST. PIL INSTALLED THE TRILOGY EVO PROPORTIONAL VALVE ON THE TRILOGY EVO TEST BE AND THEN TESTED THE PROPORTIONAL VALVE ON THE PIL TRILOGY EVO MULTIFUNCTIONAL TEST STATION FOR ACTIVE EXHALATION CONTROL MODULE (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 PRODUCT FAILED SYSTEM PRETEST. PIL INSTALLED THE TRILOGY EVO SOLENOID VALVE ON THE TRILOGY EVO TEST BED 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 ALL TESTING. PIL CONCLUDED THAT THE SOLENOID VALVE OPERATES AS DESIGNED.

    Description of Event or Problem · 0

    A VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR SERVICE. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, 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 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
    478915 TRILOGY EV300, USA VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS, INC. DS2200X11B 00606959052017

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown