BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY EVO

    MDR report key: 21591830 · Received March 13, 2025

    Report

    Report Number
    2518422-2025-033359
    Event Type
    Malfunction
    Date Received
    March 13, 2025
    Date of Event
    July 4, 2024
    Report Date
    March 13, 2025
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    CBK
    UDI-DI
    00606959054059
    PMA / PMN Number
    K181166
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    A VENTILATOR WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR SERVICE. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT THIRD-PARTY SERVICE CENTER, A "SERVICE REQUIRED" CODES WERE FOUND IN THE VENTILATOR'S DOWNLOADED ERROR LOG. THE DEVICE'S OXYGEN BLENDING MODULE NEEDS TO BE REPLACED TO ADDRESS THE ISSUES. DURING THE EVALUATION OF THE DEVICE AT THIRD-PARTY SERVICE CENTER, A "VENTILATOR INOPERATIVE " CODES WERE FOUND IN THE VENTILATOR'S DOWNLOADED ERROR LOG. THE DEVICE'S MACHINE FLOW SENSOR NEEDS TO BE REPLACED TO ADDRESS THE ISSUES. IN ADDITION OF THE ABOVE EVALUATION, BASED ON ERRORS 143, 144, 145 AND 188, THE BLOWER HAS TO BE REPLACED, BUT THERE IS NO BLOWER INSIDE THE UNIT. BASED ON ERRORS 267, 269 AND 270, THE SYSTEM PCA HAS TO BE REPLACED. AIR FOAM INLET FILTER WILL BE REPLACED DUE TO PREVENTIVE MAINTENANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1700533 TRILOGY EVO VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS, INC. IN2100X15B 00606959054059

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown