BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY 100

    MDR report key: 10771158 · Received November 2, 2020

    Report

    Report Number
    2518422-2020-02600
    Event Type
    Malfunction
    Date Received
    November 2, 2020
    Date of Event
    October 7, 2020
    Report Date
    December 7, 2020
    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
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    IN SECTION G3 OF THE INITIAL REPORT, AN INCORRECT DATE OF 01/07/2020 WAS USED. THE CORRECT DATE IS 10/07/2020.

    Description of Event or Problem · 1

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR WAS DELIVERING A HIGHER THAN SET TIDAL VOLUME. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, THE DEVICE FAILED A STEP DURING TESTING. THE DEVICE'S ACTIVE EXHALATION CONTROL MODULE NEEDS REPLACED TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1236537 TRILOGY 100 VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS INC. 1054655 00606959025387

    Patients

    Seq Age Sex Outcome Treatment
    1