BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY 100

    MDR report key: 15576751 · Received October 11, 2022

    Report

    Report Number
    2518422-2022-85898
    Event Type
    Malfunction
    Date Received
    October 11, 2022
    Date of Event
    September 14, 2022
    Report Date
    May 13, 2024
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    CBK
    UDI-DI
    00606959025387
    PMA / PMN Number
    K083526
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR FAILED TO CHARGE ITS INTERNAL BATTERY. 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 POWER MANAGEMENT BOARD NEEDS TO BE REPLACED TO ADDRESS THE ISSUE. THE REPLACED PARTS WERE SENT TO THE MANUFACTURER'S PRODUCT INVESTIGATION LABORATORY FOR INVESTIGATION. DURING THE INVESTIGATION, THE MANUFACTURER COULD NOT CONFIRM A FAULTY POWER MANAGEMENT CIRCUIT BOARD. THE POWER MANAGEMENT BOARD WAS BENCH TESTED, AND IT APPEARED TO WORK WITHOUT NOTICEABLE ISSUES. DURING THE AUTOMATED MTFS TESTING, THE POWER MANAGEMENT BOARD PASSED ALL AUTOMATED TEST STEPS LISTED ABOVE, NO PROBLEM FOUND (NPF). SECTION H4 DEVICE MANUFACTURE DATE WAS CAPTURED INCORRECTLY IN THE PREVIOUS REPORT. IT HAS BEEN UPDATED AND CORRECTED IN THIS REPORT.

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR FAILED TO CHARGE ITS INTERNAL BATTERY. 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 POWER MANAGEMENT BOARD NEEDS TO BE REPLACED TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2880702 TRILOGY 100 VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS, INC. 1054655 00606959025387

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown