BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY EVO

    MDR report key: 10244735 · Received July 8, 2020

    Report

    Report Number
    2518422-2020-01569
    Event Type
    Malfunction
    Date Received
    July 8, 2020
    Date of Event
    June 29, 2020
    Report Date
    June 29, 2020
    Manufacturer
    RESPIRONICS, INC
    Product Code
    CBK
    PMA / PMN Number
    K181166
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    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.

    Description of Event or Problem · 1

    A VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR SERVICE. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, A "SERVICE REQUIRED" CODE WAS FOUND IN THE VENTILATOR'S DOWNLOADED ERROR LOG. THE DEVICE'S SYSTEM BOARD WAS REPLACED TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    712478 TRILOGY EVO VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS, INC ND2110X15B

    Patients

    Seq Age Sex Outcome Treatment
    1