BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY EVO

    MDR report key: 12637116 · Received October 14, 2021

    Report

    Report Number
    2518422-2021-05356
    Event Type
    Malfunction
    Date Received
    October 14, 2021
    Date of Event
    September 14, 2021
    Report Date
    April 28, 2022
    Manufacturer
    RESPIRONICS, INC
    Product Code
    CBK
    UDI-DI
    00606959051942
    PMA / PMN Number
    K181166
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER PREVIOUSLY REPORTED RECEIVING INFORMATION ALLEGING A VENTILATOR FAILED TO ALARM WHEN A PATIENT'S CIRCUIT BECAME DISCONNECTED. THERE WAS NO HARM OR INJURY REPORTED. THE ISSUE WAS EVALUATED BY A FIELD SERVICE ENGINEER AND THE CUSTOMER'S COMPLAINT WAS CONFIRMED. THE DEVICE'S SOFTWARE WAS RELOADED TO ADDRESS THE ISSUE. THIS FOLLOW UP REPORT WAS INITIALLY INCORRECTLY FILED UNDER MDR 2518422-2022-05356-1.

    Description of Event or Problem · 1

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR FAILED TO ALARM WHEN A PATIENT'S CIRCUIT BECAME DISCONNECTED. THERE WAS NO HARM OR INJURY REPORTED. 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
    1531502 TRILOGY EVO VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS, INC DS2110X11B 00606959051942

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown