BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY 202

    MDR report key: 2854326 · Received November 28, 2012

    Report

    Report Number
    2518422-2012-02337
    Event Type
    Malfunction
    Date Received
    November 28, 2012
    Date of Event
    November 12, 2012
    Report Date
    November 12, 2012
    Manufacturer
    RESPIRONICS INC
    Product Code
    CBK
    PMA / PMN Number
    K093905
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DURING THE EVAL OF THE DEVICE AT THE MFR'S SERVICE CENTER, THE AC INLET CONNECTOR WAS FOUND TO BE DAMAGED. THE DEVICE'S AC INLET CONNECTOR WAS REPLACED TO ADDRESS THE ISSUE.

    Description of Event or Problem · 1

    A VENTILATOR WAS RETURNED TO THE MFR FOR SERVICE. THERE WAS NO HARM OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRILOGY 202 VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS INC 1040007

    Patients

    Seq Age Sex Outcome Treatment
    1