BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 3913095 · Received May 14, 2014

    Report

    Report Number
    8020893-2014-01146
    Event Type
    Malfunction
    Date Received
    May 14, 2014
    Date of Event
    January 1, 2014
    Report Date
    April 16, 2014
    Manufacturer
    COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT IRELAND
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF PROVIDED A FOLLOW UP REPORT WILL BE SUBMITTED. COVIDIEN REFERENCE: (B)(4).

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED FROM THE USA STATING THAT AN 840 VENTILATOR HAD A BLANK GRAPHICAL USER INTERFACE (GUI) DISPLAY. THE DEVICE WAS NOT BEING USED ON A PATIENT WHEN EVENT OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    287892 840 VENTILATOR CBK CBK COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT IRELAND 840

    Patients

    Seq Age Sex Outcome Treatment
    1