BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY 100

    MDR report key: 2854306 · Received November 28, 2012

    Report

    Report Number
    2518422-2012-02360
    Event Type
    Malfunction
    Date Received
    November 28, 2012
    Date of Event
    November 7, 2012
    Report Date
    November 7, 2012
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    CBK
    PMA / PMN Number
    K083526
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS YET TO BE RETURNED TO THE MFR FOR EVAL. AT THIS TIME, WE ARE UNABLE TO CONFIRM THE ALLEGED MALFUNCTION. A F/U REPORT WILL BE SUBMITTED WHEN THE MFR'S INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE MFR RECEIVED INFO ALLEGING A VENTILATOR'S ACTIVE EXHALATION PORT WAS FAULTY. THERE WAS NO REPORT OF HARM OR INJURY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1