BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY 202

    MDR report key: 11886744 · Received May 26, 2021

    Report

    Report Number
    2518422-2021-01415
    Event Type
    Malfunction
    Date Received
    May 26, 2021
    Date of Event
    May 10, 2021
    Report Date
    May 26, 2021
    Manufacturer
    PHILIPS RESPIRONICS INC.
    Product Code
    CBK
    UDI-DI
    00606959022706
    PMA / PMN Number
    K093905
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    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 REPORT OF PATIENT HARM OR INJURY. DURING THE EVALUATION OF THE DEVICE AT A THIRD PARTY SERVICE CENTER, "SERVICE REQUIRED" CODES WERE FOUND IN THE VENTILATOR'S DOWNLOADED ERROR LOG. THE DEVICE'S POWER MANAGEMENT BOARD, OXYGEN BLENDING MODULE BOARD AND INTERFACE BOARD WERE REPLACED TO ADDRESS THE ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    784102 TRILOGY 202 VENTILATOR, CONTINUOUS, FACILITY USE CBK PHILIPS RESPIRONICS INC. 1040000 00606959022706

    Patients

    Seq Age Sex Outcome Treatment
    1