BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY EVO

    MDR report key: 10078743 · Received May 21, 2020

    Report

    Report Number
    2518422-2020-01249
    Event Type
    Malfunction
    Date Received
    May 21, 2020
    Date of Event
    April 23, 2020
    Report Date
    April 23, 2020
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    CBK
    PMA / PMN Number
    K181166
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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.

    Description of Event or Problem · 1

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR INOPERATIVE CONDITION OCCURRED. THERE WAS NO HARM OR INJURY REPORTED. THE VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR EVALUATION AND THE CUSTOMER'S COMPLAINT WAS CONFIRMED. THE DEVICE'S SOFTWARE NEEDS RELOADED TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    544614 TRILOGY EVO VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS, INC. ES2100X15B

    Patients

    Seq Age Sex Outcome Treatment
    1