BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY 100

    MDR report key: 4180607 · Received October 15, 2014

    Report

    Report Number
    2518422-2014-01798
    Event Type
    Malfunction
    Date Received
    October 15, 2014
    Report Date
    October 13, 2014
    Manufacturer
    RESPIRONICS INC.,
    Product Code
    CBK
    PMA / PMN Number
    K083526
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, THE DEVICE WAS ALARMING. THE DEVICE'S SENSOR BOARD WAS REPLACED TO ADDRESS THE ISSUE. DEVICE HAS BEEN EVALUATED BUT THE COMPONENTS HAVE NOT BEEN REPLACED PENDING CUSTOMER APPROVAL OF ESTIMATE.

    Description of Event or Problem · 1

    A VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR SVC. THE DEVICE WAS NOT IN PT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    655852 TRILOGY 100 CBK RESPIRONICS INC., 1054097

    Patients

    Seq Age Sex Outcome Treatment
    1