BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 3901897 · Received May 7, 2014

    Report

    Report Number
    8020893-2014-01119
    Event Type
    Malfunction
    Date Received
    May 7, 2014
    Report Date
    April 14, 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

    THE INVESTIGATION INTO THIS REPORT IS ON-GOING. AS ADD'L INFO IS OBTAINED, A SUPPLEMENTAL REPORT WILL BE FILED. COVIDIEN REF: (B)(4).

    Description of Event or Problem · 1

    A REPORT REC'D FROM THE USA STATED AN 840 VENTILATOR EXPERIENCED A BLANK GRAPHICAL USER INTERFACE (GUI) DISPLAY. THERE WAS NO REPORT OF PATIENT INVOLVEMENT. THE DATE OF THE EVENT IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    276841 840 VENTILATOR CBK COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT IRELAND 840

    Patients

    Seq Age Sex Outcome Treatment
    1