BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY O2

    MDR report key: 2801064 · Received October 17, 2012

    Report

    Report Number
    2518422-2012-02102
    Event Type
    Malfunction
    Date Received
    October 17, 2012
    Date of Event
    September 24, 2012
    Report Date
    September 24, 2012
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    CBK
    PMA / PMN Number
    K093905
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, AN ISSUE RELATED TO THE SENSOR BOARD WAS OBSERVED. THE DEVICE'S SENSOR BOARD WAS REPLACED TO ADDRESS THE ISSUE.

    Description of Event or Problem · 1

    A VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR ROUTINE PREVENTIVE MAINTENANCE. THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION. THE DEVICE WAS NOT IN PT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRILOGY O2 VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS, INC. 1040004

    Patients

    Seq Age Sex Outcome Treatment
    1