BEUDAMED
    FDA Adverse Event Injury Summary report: N

    840 VENTILATOR

    MDR report key: 3893926 · Received June 11, 2014

    Report

    Report Number
    8020893-2014-01415
    Event Type
    Injury
    Date Received
    June 11, 2014
    Date of Event
    May 11, 2014
    Report Date
    May 19, 2014
    Manufacturer
    COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT IRELAND
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    NO ADDITIONAL INFO IS AVAILABLE AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    A REPORT RECEIVED FROM (B)(6) STATED AN 840 VENTILATOR EXPERIENCED AN ERRATIC UPPER GRAPHICAL USER INTERFACE (GUI) DISPLAY; WHILE BEING USED ON A PATIENT. THE PATIENT WAS REMOVED FROM THE DEVICE AND PLACED ON AN ALTERNATE VENTILATOR. THE PT WAS NOT HARMED OR INJURED AS A RESULT OF THE REPORT EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    346206 840 VENTILATOR CBK COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT IRELAND 840

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention