BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 3901803 · Received May 8, 2014

    Report

    Report Number
    8020893-2014-01109
    Event Type
    Malfunction
    Date Received
    May 8, 2014
    Report Date
    April 10, 2014
    Manufacturer
    COVIDIEN, FORMERLY NELLCO
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVALUATION AND REPAIR OF THE DEVICE HAS NOT BEEN COMPLETED. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER FROM THE UNITED STATES REPORTED THAT AN 840 VENTILATOR TOUCH FRAME PANEL HAD SCREEN BLOCK ERROR. THE DEVICE WAS NOT BEING USED ON A PATIENT WEN EVENT OCCURRED. THE DATE OF THE EVENT IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279962 840 VENTILATOR CBK COVIDIEN, FORMERLY NELLCO 840

    Patients

    Seq Age Sex Outcome Treatment
    1