BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY 100

    MDR report key: 6120421 · Received November 22, 2016

    Report

    Report Number
    2518422-2016-04552
    Event Type
    Malfunction
    Date Received
    November 22, 2016
    Date of Event
    October 28, 2016
    Report Date
    October 28, 2016
    Manufacturer
    RESPIRONICS, INC
    Product Code
    CBK
    UDI-DI
    00606959015364
    PMA / PMN Number
    K083526
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    A VENTILATOR WAS RETURNED TO A THIRD PARTY SERVICE CENTER FOR EVALUATION. THE DEVICE WAS NOT IN PATIENT USE. DURING THE EVALUATION OF THE DEVICE AT THE THIRD PARTY SERVICE CENTER, A "SERVICE REQUIRED" CODE WAS FOUND IN THE VENTILATOR'S DOWNLOADED ERROR LOG. THE DEVICE'S INTERNAL BATTERY WAS REPLACED TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    772106 TRILOGY 100 VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS, INC 1054260 00606959015364

    Patients

    Seq Age Sex Outcome Treatment
    1