BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY 100

    MDR report key: 3960326 · Received June 23, 2014

    Report

    Report Number
    2518422-2014-01047
    Event Type
    Malfunction
    Date Received
    June 23, 2014
    Date of Event
    June 19, 2014
    Report Date
    June 19, 2014
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    CBK
    PMA / PMN Number
    K083526
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE VENTILATOR WAS RETURNED TO THE MFR FOR EVAL AND THE CUSTOMER'S COMPLAINT WAS CONFIRMED. CONTAMINATION WAS OBSERVED ON THE SENSOR BOARD CAUSING THE REPORTED ISSUE. THE DEVICE'S SENSOR BOARD WAS REPLACE THE ADDRESS THE ISSUE.

    Description of Event or Problem · 1

    THE MFR RECEIVED INFO ALLEGING A "SERVICE REQUIRED" ALARM CONDITION OCCURRED. THERE WAS NO HARM OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    366276 TRILOGY 100 VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS, INC. 1054260

    Patients

    Seq Age Sex Outcome Treatment
    1