BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY 100

    MDR report key: 3130207 · Received May 22, 2013

    Report

    Report Number
    2518422-2013-00931
    Event Type
    Malfunction
    Date Received
    May 22, 2013
    Date of Event
    April 26, 2013
    Report Date
    April 26, 2013
    Manufacturer
    RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP
    Product Code
    CBK
    PMA / PMN Number
    K083526
    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 A VENTILATOR SHUT DOWN WHILE IN USE. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE HAS NOT YET BEEN EVALUATED BY THE MFR. 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
    227359 TRILOGY 100 VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP 1054655

    Patients

    Seq Age Sex Outcome Treatment
    1