BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY 100

    MDR report key: 8821750 · Received July 24, 2019

    Report

    Report Number
    2518422-2019-01611
    Event Type
    Malfunction
    Date Received
    July 24, 2019
    Date of Event
    July 9, 2019
    Report Date
    July 9, 2019
    Manufacturer
    PHILIPS RESPIRONICS INC.
    Product Code
    CBK
    PMA / PMN Number
    K083526
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    A VENTILATOR WAS RETURNED TO A THIRD PARTY SERVICE CENTER FOR EVALUATION. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT A THIRD PARTY SERVICE CENTER, A "VENTILATOR INOPERATIVE" CODE WAS FOUND IN THE VENTILATOR'S DOWNLOADED ERROR LOG. THE DEVICE'S BLOWER MOTOR WAS REPLACED TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    616043 TRILOGY 100 VENTILATOR, CONTINUOUS, FACILITY USE CBK PHILIPS RESPIRONICS INC. 1054260

    Patients

    Seq Age Sex Outcome Treatment
    1