BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 3964646 · Received May 30, 2014

    Report

    Report Number
    8020893-2014-01308
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Date of Event
    May 5, 2014
    Report Date
    May 5, 2014
    Manufacturer
    COVIDIEN, FORMERLY NELLCOR
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CSE COMPLETED THE DATA KEY SERVICE AND INSTALLED THE LATEST VERSION OF SOFTWARE TO THE DEVICE. THE VENTILATOR PASSED ALL CALIBRATION, SELF-TESTS AND SAFETY TESTS AND REMAINS WITHIN THE CUSTOMER. THE CSE REPORTED THAT THE CUSTOMER WILL BE COMPLETING THE REPAIR OF THE GUI DISPLAY. (B)(4).

    Description of Event or Problem · 1

    A COVIDIEN CUSTOMER SERVICE ENGINEER (CSE) IN (B)(6) REPORTED THAT DURING DATA KEY INSTALLATION HE FOUND THAT THE GRAPHICAL USER INTERFACE (GUI) LOWER DISPLAY OF AN 840 VENTILATOR WAS ERRATIC AND DIFFICULT TO READ. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320069 840 VENTILATOR CBK COVIDIEN, FORMERLY NELLCOR 840

    Patients

    Seq Age Sex Outcome Treatment
    1