BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 2925336 · Received January 17, 2013

    Report

    Report Number
    8020893-2013-00132
    Event Type
    Malfunction
    Date Received
    January 17, 2013
    Date of Event
    January 7, 2013
    Report Date
    January 7, 2013
    Manufacturer
    COVIDIEN, FORMERLY NELLCO
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED NONE OF THE BUTTONS ON THE DISPLAY SCREEN ARE WORKING ON THE 840 VENTILATOR. NO PT INVOLVEMENT. THE CUSTOMER REPORTED TO HAVE REPLACED THE GUI CABLE. THE VENTILATOR PASSED ALL TESTING. COVIDIEN WAS NOT AUTHORIZED TO SERVICE THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25524 840 VENTILATOR VENTILATOR CBK COVIDIEN, FORMERLY NELLCO 840

    Patients

    Seq Age Sex Outcome Treatment
    1