BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY 100

    MDR report key: 3070266 · Received April 16, 2013

    Report

    Report Number
    2518422-2013-00621
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Report Date
    April 12, 2013
    Manufacturer
    RESPIRONICS INC.
    Product Code
    CBK
    PMA / PMN Number
    K083526
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION AND THE CUSTOMER'S COMPLAINT WAS CONFIRMED. THE DEVICE'S SENSOR BOARD WAS REPLACED TO ADDRESS THE ISSUE. THE SENSOR BOARD WAS FORWARDED TO THE MANUFACTURER'S QUALITY ASSURANCE LABORATORY FOR FURTHER INVESTIGATION. THE BOARD'S FLOW SENSOR WAS CONFIRMED TO HAVE DRIFTED OUT OF TOLERANCE.

    Description of Event or Problem · 1

    THE MANUFACTURER RECEIVED INFORMATION FROM A THIRD PARTY SERVICE CENTER ALLEGING A VENTILATOR FAILED A STEP DURING TESTING. THERE WAS NO HARM OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163971 TRILOGY 100 VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS INC. 1054096

    Patients

    Seq Age Sex Outcome Treatment
    1