BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY 100

    MDR report key: 4092789 · Received August 20, 2014

    Report

    Report Number
    2518422-2014-01397
    Event Type
    Malfunction
    Date Received
    August 20, 2014
    Date of Event
    July 29, 2014
    Report Date
    July 29, 2014
    Manufacturer
    RESPIRONICS INC
    Product Code
    CBK
    PMA / PMN Number
    K083526
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DURING THE EVAL OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, THE DEVICE FAILED A STEP DURING TESTING. THE DEVICE'S SENSOR BOARD WAS REPLACED TO ADDRESS THE ISSUE.

    Description of Event or Problem · 1

    A VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR SERVICE. THERE WAS NO HARM OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    500553 TRILOGY 100 VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS INC 1054655

    Patients

    Seq Age Sex Outcome Treatment
    1