BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY EV300, USA

    MDR report key: 24442333 · Received February 25, 2026

    Report

    Report Number
    2518422-2026-006415
    Event Type
    Malfunction
    Date Received
    February 25, 2026
    Date of Event
    January 28, 2026
    Report Date
    May 27, 2026
    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
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER PREVIOUSLY REPORTED A VENTILATOR FAILED AN ACTIVE EXHALATION VERIFICATION (AECM) TEST STEP DURING TESTING. THERE WAS NO HARM OR INJURY REPORTED. THERE WAS NO EVIDENCE THE DEVICE WAS IN PATIENT USE. THE MANUFACTURER'S FIELD SERVICE ENGINEER HAS BEEN DISPATCHED TO REPLACE THE DEVICE'S THREE-WAY SOLENOID VALVE AND PROPORTIONAL VALVE TO ADDRESS THE ISSUE. THE COMPONENTS WERE RETURNED TO THE MANUFACTURER'S PRODUCT INVESTIGATION LABORATORY (PIL) FOR EVALUATION. THE PROPORTIONAL VALVE WAS PLACED ON A MULTIFUNCTIONAL TEST STATION AND PASSED ALL AECM VERIFICATION TEST STEPS. THE PIL CONCLUDES THE COMPONENT OPERATES AS DESIGNED. THE SOLENOID VALVE WAS PLACED ON A MULTIFUNCTIONAL TEST STATION AND FAILED THE AECM VERIFICATION TEST STEPS. THE PIL CONCLUDES THE SOLENOID VALVE IS FAULTY. THE REPORTED FAILURE OF THE AECM VERIFICATION TEST STEP IS ACCOMMODATED IN THE PRODUCT RISK MANAGEMENT FILE AS BEING LINKED TO HAZARD WITH DESCRIPTION PATIENT EXPOSURE TO FUNCTION / DETERIORATION OF FUNCTION. COMPLAINTS FOR THIS FAILURE ARE REVIEWED VIA THE POST MARKET COMPLAINT TRENDING AND ESCALATION PROCESSES TO ASSESS FOR THE OBSERVED PROBABILITY LEVELS AND COMPARE THEM WITH THE PREDICTED LEVELS IN THE RISK FILE FOR THE HAZARDS LINKED TO THE FAILURE. AS OF THE DATE OF SUBMISSION FOR THIS REPORT, THERE IS NO INDICATION THAT COMPLAINTS FOR THE FAILURE IN QUESTION HAS LED TO UNACCEPTABLE INCREASE IN PROBABILITY LEVELS FOR THE HAZARDOUS SITUATIONS IN SCOPE, AND THEREFORE NO FURTHER ACTION WILL BE PURSUED. QA CONTINUES TO MONITOR COMPLAINTS FOR THIS ISSUE PER THE CADENCE IN THE COMPLAINT TRENDING PROCEDURES. DHR REVIEW: THE DEVICE MENTIONED IN THIS COMPLAINT HAS EXCEEDED ITS USEFUL LIFE PER THE APPLICABLE IFU.

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR FAILED AN ACTIVE EXHALATION VERIFICATION TEST STEP DURING TESTING. THERE WAS NO HARM OR INJURY REPORTED. THERE WAS NO EVIDENCE THE DEVICE WAS IN PATIENT USE. THE MANUFACTURER'S FIELD SERVICE ENGINEER HAS BEEN DISPATCHED TO REPLACE THE DEVICE'S THREE-WAY SOLENOID VALVE AND PROPORTIONAL VALVE 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
    238561 TRILOGY EV300, USA VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS, INC. DS2200X11B 00606959052017

    Patients

    Seq Age Sex Outcome Treatment
    1