BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY 100

    MDR report key: 4113773 · Received September 17, 2014

    Report

    Report Number
    2518422-2014-01582
    Event Type
    Malfunction
    Date Received
    September 17, 2014
    Date of Event
    August 26, 2014
    Report Date
    August 26, 2014
    Manufacturer
    RESPIRONICS INC.
    Product Code
    CBK
    PMA / PMN Number
    K083526
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR EVALUATION AND THE CUSTOMER'S COMPLAINT WAS CONFIRMED. THE DEVICE'S SYSTEM BOARD WILL BE REPLACED TO ADDRESS THE ISSUE. CONCLUSIONS: THE EVAL OF THE DEVICE IS COMPLETE, PENDING CUSTOMER APPROVAL OF THE ESTIMATE.

    Description of Event or Problem · 1

    THE MFR RECEIVED INFO FROM A THIRD PARTY SERVICE CENTER ALLEGING A VENTILATOR FAILED A STEP DURING TESTING. THE DEVICE WAS NOT IN PT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    576025 TRILOGY 100 VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS INC. 1054097

    Patients

    Seq Age Sex Outcome Treatment
    1