BEUDAMED
    FDA Adverse Event Death Summary report: N

    TRILOGY 100

    MDR report key: 6106606 · Received November 16, 2016

    Report

    Report Number
    2518422-2016-04535
    Event Type
    Death
    Date Received
    November 16, 2016
    Date of Event
    November 4, 2016
    Report Date
    November 7, 2016
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    CBK
    UDI-DI
    00606959033894
    PMA / PMN Number
    K083526
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING A PATIENT EXPIRED WHILE USING A VENTILATOR. ACCORDING TO THE REPORTER OF THE EVENT, THE PATIENT WAS FOUND TO BE IN DISTRESS BY HIS FAMILY ON (B)(6) 2016 AT 01:43 AM LOCAL TIME. THE FAMILY BEGAN CARDIOPULMONARY RESUSCITATION AND THE PATIENT WAS TAKEN TO THE HOSPITAL WHERE HE LATER EXPIRED. THE VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. THE DEVICE PASSED ALL TESTING AND WAS FOUND TO OPERATE AND ALARM AS DESIGNED. THE DEVICE'S DOWNLOADED EVENT LOGS WERE REVIEWED. THE DEVICE EVENT LOGS INCLUDE EVERY KEYPRESS, ALARM, OR FAILURE OF THE DEVICE TO REMAIN WITHIN SPECIFICATIONS. NO ERRORS WERE OBSERVED IN THE DEVICE EVENT LOG THAT WOULD INDICATE A MALFUNCTION OR FAILURE TO DELIVER THERAPY OCCURRED. THE MANUFACTURER CONCLUDES THE VENTILATOR OPERATED AND ALARMED AS DESIGNED. THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    756194 TRILOGY 100 VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS, INC. 1054655 00606959033894

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death