BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY 202

    MDR report key: 23791126 · Received December 12, 2025

    Report

    Report Number
    2518422-2025-058975
    Event Type
    Malfunction
    Date Received
    December 12, 2025
    Date of Event
    October 9, 2023
    Report Date
    December 12, 2025
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    CBK
    UDI-DI
    00606959005150
    PMA / PMN Number
    K093905
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING A "VENTILATOR SERVICE NOW" ERROR OCCURRED. THERE WAS NO HARM OR INJURY REPORTED. THE VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR EVALUATION, THE CUSTOMER¿S COMPLAINT WAS CONFIRMED, AND A "SERVICE REQUIRED" CODES WERE FOUND IN THE VENTILATOR'S DOWNLOADED ERROR LOG. THE DEVICE'S OXYGEN, BOARD KIT AND WIRE HARNESS NEED TO BE REPLACED TO ADDRESS THE ISSUES. ADDITIONALLY, INSPECTED DEVICE PER PUR PUR5103123 V02; DEVICE DID NOT COME IN WITH EITHER A THREADED CAP OR POWER CABLE, SO I WILL PROVIDE ONE OF EACH. INCOMING CTQ SCREENING PER 1002735 V19 SHOWS NO DAMAGED COMPONENTS. WHILE REPLACING THE OBM PCA, IT WAS FOUND THAT ONE OF THE FLOW ELEMENTS WAS SIGNIFICANTLY YELLOWED. THE DEVICE PASSED FINAL TEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2769517 TRILOGY 202 VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS, INC. 1040007 00606959005150

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown