BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY EVO

    MDR report key: 10322805 · Received July 24, 2020

    Report

    Report Number
    2518422-2020-01747
    Event Type
    Malfunction
    Date Received
    July 24, 2020
    Date of Event
    June 26, 2020
    Report Date
    June 26, 2020
    Manufacturer
    RESPIRONICS, INC
    Product Code
    CBK
    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 THE INCORRECT 510K NUMBER AS K18166. THE CORRECT 510K NUMBER IS K181166 AND IS REFLECTED IN G5.

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER PREVIOUSLY REPORTED RECEIVING INFORMATION ALLEGING A VENTILATOR INOPERATIVE CONDITION OCCURRED. THE DEVICE WAS RETURNED TO A THIRD PARTY SERVICE CENTER AND THE CUSTOMER'S COMPLAINT WAS CONFIRMED. THE SYSTEM BOARD WAS REPLACED TO ADDRESS THE ISSUE. THE SYSTEM BOARD WAS RETURNED TO THE MANUFACTURER'S PRODUCT INVESTIGATION LABORATORY FOR EVALUATION AND THE ROOT CAUSE OF THE SYSTEM BOARD FAILING WAS DUE TO A SOFTWARE ISSUE.

    Description of Event or Problem · 1

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR INOPERATIVE CONDITION OCCURRED. THE DEVICE WAS NOT IN PATIENT USE. THE DEVICE HAS YET TO BE EVALUATED BY 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
    786819 TRILOGY EVO VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS, INC DS2110X11B

    Patients

    Seq Age Sex Outcome Treatment
    1