BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY EVO

    MDR report key: 14335243 · Received May 9, 2022

    Report

    Report Number
    2518422-2022-18177
    Event Type
    Malfunction
    Date Received
    May 9, 2022
    Date of Event
    April 15, 2022
    Report Date
    May 25, 2022
    Manufacturer
    RESPIRONICS, INC
    Product Code
    CBK
    UDI-DI
    00606959051942
    PMA / PMN Number
    K181166
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER PREVIOUSLY REPORTED A VENTILATOR WAS ALARMING FOR A VENTILATOR INOPERATIVE ALARM CONDITION. THE VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR EVALUATION AND THE CUSTOMER'S COMPLAINT WAS CONFIRMED. THE DEVICE'S MACHINE FLOW SENSOR AND SYSTEM BOARD WERE REPLACED TO ADDRESS THE ISSUE. THIS ISSUE WAS INITIALLY REPORTED INCORRECTLY ON MDR 2518422-2022-18117-1.

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR INOPERATIVE CONDITION OCCURRED. THE DEVICE WAS NOT IN PATIENT USE. THE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER. AT THIS TIME, WE ARE UNABLE TO CONFIRM THE ALLEGED MALFUNCTION. 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
    1443072 TRILOGY EVO VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS, INC DS2110X11B 00606959051942

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown