BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY 100

    MDR report key: 12198761 · Received July 20, 2021

    Report

    Report Number
    2518422-2021-02349
    Event Type
    Malfunction
    Date Received
    July 20, 2021
    Date of Event
    July 14, 2021
    Report Date
    July 21, 2021
    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 PREVIOUSLY REPORTED THE INCORRECT 510K NUMBER IN SECTION G4. THE CORRECT NUMBER IS K083526 AND IS REFLECTED IN THIS REPORT.

    Description of Event or Problem · 1

    A VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR ROUTINE PREVENTATIVE MAINTENANCE. THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION. THE DEVICE WAS NOT IN PATIENT USE. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, THE DEVICE FAILED A TEST STEP DURING TESTING. THE DEVICE'S ACTIVE EXHALATION CONTROL MODULE WAS REPLACED TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1092354 TRILOGY 100 VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS, INC 1054655 00606959025387

    Patients

    Seq Age Sex Outcome Treatment
    1