BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY 200

    MDR report key: 2575667 · Received May 2, 2012

    Report

    Report Number
    2518422-2012-00580
    Event Type
    Malfunction
    Date Received
    May 2, 2012
    Date of Event
    April 4, 2012
    Report Date
    April 4, 2012
    Manufacturer
    RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP
    Product Code
    CBK
    PMA / PMN Number
    K093416
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE MFR RECEIVED INFO ALLEGING THE VENTILATOR¿S SETTINGS CHANGED FROM ACTIVE FLOW MODE TO ACTIVE PAP MODE. THERE WAS NO PT HARM OR INJURY REPORTED. THE DEVICE HAS YET TO BE EVALUATED. AT THIS TIME WE ARE UNABLE TO CONFIRM THE ALLEGED MALFUNCTION. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE MFR¿S INVESTIGATION IS COMPLETE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRILOGY 200 VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP 1032804

    Patients

    Seq Age Sex Outcome Treatment
    1