BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY EVO

    MDR report key: 18491305 · Received January 11, 2024

    Report

    Report Number
    2518422-2024-01969
    Event Type
    Malfunction
    Date Received
    January 11, 2024
    Date of Event
    November 6, 2023
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    CBK
    PMA / PMN Number
    K181166
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING A TRILOGY EVO VENTILATOR FAILURE " FREE FIO2 FLOW". THERE WAS NO HARM OR INJURY REPORTED. THE TRILOGY EVO VENTILATOR WAS SENT TO A THIRD-PARTY SERVICE CENTER FOR EVALUATION. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, THE CUSTOMER COMPLAINT WAS CONFIRMED AND ERROR CODES E-80 AND E-81WERE FOUND IN THE VENTILATOR'S DOWNLOADED ERROR LOG. THE DEVICE'S OMB AND OMB HARNESS WAS REPLACED TO ADDRESS THE ISSUE. THE AIR FOAM INLET FILTER WAS REPLACED DUE TO PREVENTIVE MAINTENANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    647185 TRILOGY EVO VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS, INC. IN2100X15B

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown