BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY 100

    MDR report key: 3102277 · Received April 30, 2013

    Report

    Report Number
    2518422-2013-00712
    Event Type
    Malfunction
    Date Received
    April 30, 2013
    Date of Event
    April 4, 2013
    Report Date
    April 4, 2013
    Manufacturer
    RESPIRONICS INC.
    Product Code
    CBK
    PMA / PMN Number
    K083526
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE VENTILATOR WAS RETURNED TO THE MFR FOR EVAL AND THE CUSTOMER'S COMPLAINT WAS CONFIRMED. THE DEVICE WAS RECALIBRATED TO ADDRESS THE ISSUE.

    Description of Event or Problem · 1

    THE MFR RECEIVED INFORMATION ALLEGING A DISCREPANCY BETWEEN A VENTILATOR'S SET VOLUME AND THE ACTUAL VOLUME THAT WAS DELIVERED. THE DEVICE WAS NOT IN PT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    187823 TRILOGY 100 VENTILATOR, CONITNUOUS, FACILITY USE CBK RESPIRONICS INC. 1054655

    Patients

    Seq Age Sex Outcome Treatment
    1