BEUDAMED
    FDA Adverse Event Death Summary report: N

    TRILOGY 100

    MDR report key: 4091899 · Received August 20, 2014

    Report

    Report Number
    2518422-2014-01428
    Event Type
    Death
    Date Received
    August 20, 2014
    Date of Event
    July 25, 2014
    Report Date
    August 15, 2014
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    CBK
    PMA / PMN Number
    K083526
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING A PATIENT EXPIRED WHILE ON A VENTILATOR. THE CAREGIVER ENTERED THE ROOM AND FOUND THE VENTILATOR UNPLUGGED FROM AC POWER. THE DEVICE HAS YET TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    503731 TRILOGY 100 VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS, INC. 1054096

    Patients

    Seq Age Sex Outcome Treatment
    1 Death