BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY EV300, USA

    MDR report key: 24643861 · Received March 19, 2026

    Report

    Report Number
    2518422-2026-009795
    Event Type
    Malfunction
    Date Received
    March 19, 2026
    Date of Event
    March 12, 2026
    Report Date
    May 28, 2026
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    CBK
    UDI-DI
    00606959052017
    PMA / PMN Number
    K181166
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER PREVIOUSLY RECEIVED INFORMATION ALLEGING THAT A TRILOGY EV300 DEVICE FAILED THE ACTIVE EXHALATION TEST PRIOR TO IMPLEMENTATION OF A FIELD CORRECTIVE ACTION (FCA) OR FIELD CHANGE ORDER (FCO). THERE WAS NO REPORT OF PATIENT HARM. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF THE EVENT. DURING EVALUATION AT THE MANUFACTURER'S SERVICE CENTER, THE REPORTED ISSUE WAS CONFIRMED. THE SERVICE TECHNICIAN REPLACED THE PROPORTIONAL VALVE (AECM) AND 3-WAY SOLENOID VALVE IN ACCORDANCE WITH THE FIELD SERVICE MANUAL. FOLLOWING REPAIR, THE DEVICE PASSED ALL REQUIRED PERFORMANCE AND VERIFICATION TESTING AND WAS RETURNED TO SERVICE. THE REMOVED PROPORTIONAL VALVE (AECM) AND 3-WAY SOLENOID VALVE WERE RETURNED TO THE MANUFACTURER'S PRODUCT INVESTIGATION LABORATORY (PIL) FOR FURTHER EVALUATION. THE PROPORTIONAL VALVE WAS INSTALLED ON A TRILOGY EVO STB UNIT AND TESTED USING THE TRILOGY EVO MULTIFUNCTIONAL TEST STATION. THE COMPONENT PASSED AECM VERIFICATION TESTING AT PRETEST AND POSTTEST. THE INVESTIGATION CONCLUDED THAT THE PROPORTIONAL VALVE OPERATED AS DESIGNED. THE 3-WAY SOLENOID VALVE WAS ALSO INSTALLED ON A TRILOGY EVO STB UNIT AND EVALUATED USING THE TRILOGY EVO MULTIFUNCTIONAL TEST STATION. THE COMPONENT PASSED AECM VERIFICATION AND AECM SOLENOID CURRENT VERIFICATION TESTING AT POSTTEST; HOWEVER, IT FAILED AECM VERIFICATION TESTING AT PRETEST. THE RESULTS ARE INDICATIVE OF A FAULTY SOLENOID VALVE. THE INVESTIGATION BY ENGINEERING IS ONGOING.

    Description of Event or Problem · 0

    THE MANUFACTURE RECEIVED INFORMATION THAT AN EV300 USA DEVICE WAS BEING USED TO CREATE A TREATMENT PLAN FOR RESPIRATORY ASSIST AND NEEDS O2 CALIBRATION. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE WAS NOT REPORTED TO BE IN PATIENT USE. DURING THE EVALUATION OF THE TRILOGY EV300, USA DEVICE BY THE FIELD SERVICE ENGINEER (FSE), THE DEVICE FAILED THE SENSOR DRIFT VERIFICATION. THE FSE REPORTED THE FAILURE OF THE FLOW SENSOR, ACTIVE EXHALATION CONTROL MODULE (AECM) AND THE 3-WAY VALVE RESULTED IN INACCURATE READINGS, WHICH CAUSED THE DEVICE TO FAIL TESTING. REPLACING THE DEVICE'S ACTIVE EXHALATION CONTROL MODULE, 3-WAY SOLENOID VALVES AND FLOW SENSOR RESOLVED 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
    331179 TRILOGY EV300, USA VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS, INC. DS2200X11B 00606959052017

    Patients

    Seq Age Sex Outcome Treatment
    1