BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 3955648 · Received June 11, 2014

    Report

    Report Number
    8020893-2014-01407
    Event Type
    Malfunction
    Date Received
    June 11, 2014
    Date of Event
    January 1, 2014
    Report Date
    May 14, 2014
    Manufacturer
    COVIDIEN,NELLCOR PURITAN BENNETT IRELAND
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COVIDIEN CUSTOMER SUPPORT ENGINEER (CSE) VERIFIED THE MALFUNCTION. THE CSE INSPECTED THE DEVICE AND REPLACED THE GUI TOUCH-FRAME. THE DEVICE PASSED THE PERFORMANCE VERIFICATION TEST (PVT). (B)(4).

    Description of Event or Problem · 1

    A REPORT RECEIVED FROM THE USA STATED AN 840 VENTILATOR EXPERIENCED A GRAPHICAL USER INTERFACE (GUI) TOUCH SCREEN ERROR ISSUE. THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344560 840 VENTILATOR CBK COVIDIEN,NELLCOR PURITAN BENNETT IRELAND 840

    Patients

    Seq Age Sex Outcome Treatment
    1