BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY 100

    MDR report key: 2850195 · Received November 21, 2012

    Report

    Report Number
    2518422-2012-02258
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Date of Event
    October 30, 2012
    Report Date
    October 30, 2012
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    CBK
    PMA / PMN Number
    K083526
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DURING THE EVAL OF THE DEVICE AT THE MFR'S SVC CTR, THE AC INLET CONNECTOR WAS FOUND TO BE DAMAGED. THE VENTILATOR'S AC INLET CONNECTOR WAS REPLACED TO ADDRESS THIS ISSUE.

    Description of Event or Problem · 1

    THE MFR RECEIVED INFO ALLEGING A VENTILATOR'S POWER PORT (AC INLET) WAS BROKEN. 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. 1054260

    Patients

    Seq Age Sex Outcome Treatment
    1