BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY 200

    MDR report key: 19239681 · Received May 3, 2024

    Report

    Report Number
    2518422-2024-24932
    Event Type
    Malfunction
    Date Received
    May 3, 2024
    Date of Event
    April 26, 2024
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    CBK
    UDI-DI
    00606959022683
    PMA / PMN Number
    K093416
    Removal / Correction Number
    Z-0883-2023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PREVIOUSLY REPORTED: A TRILOGY 200 VENTILATOR WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR FOAM REPLACEMENT PER FIELD ACTION: C&R 2021-05/06. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, A "SERVICE REQUIRED" CODE WAS FOUND IN THE VENTILATOR'S DOWNLOADED ERROR LOG. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE. NEW INFORMATION: A TRILOGY200 VENTILATOR WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR FOAM REPLACEMENT PER FIELD ACTION: C&R 2021-05/06. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, NO ERRORS OCCURRED DURING THE 30SECOND RUN-IN EVALUATION.

    Description of Event or Problem · 0

    A TRILOGY 200 VENTILATOR WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR FOAM REPLACEMENT PER FIELD ACTION: C&R 2021-05/06. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, A "SERVICE REQUIRED" CODE WAS FOUND IN THE VENTILATOR'S DOWNLOADED ERROR LOG. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1493060 TRILOGY 200 VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS, INC. 1032800 00606959022683

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown