BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY EVO

    MDR report key: 23635915 · Received November 24, 2025

    Report

    Report Number
    2518422-2025-112033
    Event Type
    Malfunction
    Date Received
    November 24, 2025
    Date of Event
    November 12, 2025
    Report Date
    February 12, 2026
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    CBK
    UDI-DI
    00606959054127
    PMA / PMN Number
    K181166
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER PREVIOUSLY REPORTED A VENTILATOR WAS ALARMING FOR A PRESSURE SENSOR MISMATCH ALARM CONDITION. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE WAS NOT IN PATIENT USE. THIS NOTIFICATION 2518422-2025-112033 IS A DUPLICATE OF 2518422-2025-112209/ 2518422-2025-112209-001. THE DEVICE WAS RETURNED AND THE ISSUE DOCUMENTED ON THE PR 1090785 NOTIFICATION THAT CONTAINED THE REPAIR EVALUATION. THE REPAIR EVALUATION CONTAINED THE FOLLOWING REPAIR INFORMATION. THE MANUFACTURER PREVIOUSLY REPORTED A VENTILATOR WAS CONTINUOUSLY ALARMING FOR A PRESSURE SENSOR MISMATCH ALARM CONDITION. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE WAS NOT IN PATIENT USE. THE DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR EVALUATION. THE PRESSURE SENSOR MISMATCH ALARM WAS CONFIRMED. THE REPAIR RECOMMENDED WAS TO INSPECT THE AIR PATHWAY FOR ENVIRONMENTAL DEBRIS OR CONTAMINATION AND IF PRESENT REPLACE THE AIR PATHWAY COMPONENTS. THE DEVICE'S PARTICULATE FILTER, FILTER COVER, AIR INLET FOAM FILTER, BLOWER ASSEMBLY, BLOWER BELLOWS SEAL, BLOWER MOUNT, PROPORTIONAL VALVE, BLOWER CAP, DUAL LIMB CUP, MACHINE FLOW SENSOR, BLOWER CHASSIS PLATE, SYSTEM BOARD TUBING, BLOWER CHASSIS TUBING, FIO2 TUBING, LOW FLOW O2 TUBING, THREE-WAY SOLENOID VALVE, LOW FLOW O2 CONNECTOR, OUTSIDE PANEL, FIO2 HOUSING, MUFFLER ASSEMBLY AND SYSTEM BOARD NEED TO BE REPLACED. NO REPAIRS WERE PERFORMED. THE DEVICE WAS SCRAPPED PER THE CUSTOMER'S REQUEST. THIS NOTIFICATION WILL BE CLOSED OUT AS A DUPLICATE ISSUE.

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR WAS ALARMING FOR A "SERVICE REQUIRED" ALARM CONDITION INDICATING A PRESSURE SENSOR MISMATCH OCCURRED. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE HAS NOT YET BEEN RETURNED FOR EVALUATION. AT THIS TIME, WE ARE UNABLE TO CONFIRM THE ALLEGED MALFUNCTION. IF ANY ADDITIONAL INFORMATION IS RECEIVED ONCE THE INVESTIGATION IS COMPLETE, A FOLLOW-UP REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2388500 TRILOGY EVO VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS, INC. GB2110X15B 00606959054127

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown