BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY EVO, O2, BRAZIL

    MDR report key: 20164169 · Received September 6, 2024

    Report

    Report Number
    2518422-2024-100399
    Event Type
    Malfunction
    Date Received
    September 6, 2024
    Date of Event
    August 8, 2024
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    CBK
    PMA / PMN Number
    K181166
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE TRILOGY EVO, BRAZIL (BR2110X18B) IS SUBSTANTIALLY SIMILAR TO THE TRILOGY EVO (DS2100X11B) AND WILL BE REPORTED IN THE UNITED STATES UNDER TRILOGY EVO 501K NUMBER: K181166.

    Description of Event or Problem · 0

    A VENTILATOR WAS RETURNED TO THE MANUFACTURER'S FACTORY AUTHORIZED SERVICE CENTER FOR SERVICE. THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION. THE DEVICE WAS NOT IN PATIENT USE. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, IT WAS NOTED THAT THE DEVICE'S FLOW SENSOR FAILED. THE DEVICE'S FLOW SENSOR WAS REPLACED TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1302594 TRILOGY EVO, O2, BRAZIL VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS, INC. BR2100X18B

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown