BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY 100

    MDR report key: 2820263 · Received October 31, 2012

    Report

    Report Number
    2518422-2012-02195
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Date of Event
    October 4, 2012
    Report Date
    October 4, 2012
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    CBK
    PMA / PMN Number
    K083526
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, THE VENTILATOR'S DISPLAY SCREEN WAS FOUND TO BE DEFECTIVE. THE VENTILATOR'S SYSTEM BOARD WAS REPLACED TO ADDRESS THIS ISSUE.

    Description of Event or Problem · 1

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR'S DISPLAY SCREEN IS DEFECTIVE. THERE WAS NO HARM OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRILOGY 100 VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS, INC. 1054097

    Patients

    Seq Age Sex Outcome Treatment
    1