BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 3070597 · Received April 17, 2013

    Report

    Report Number
    8020893-2013-00853
    Event Type
    Malfunction
    Date Received
    April 17, 2013
    Date of Event
    March 21, 2013
    Report Date
    March 21, 2013
    Manufacturer
    COVIDIEN, FORMERLY NELL
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE 840 VENTILATOR SCREEN WENT BLANK WHILE IN USE ON A PT. THE PT WAS HOT HARMED OR INJURED AS A RESULT OF THE EVENT. THE COVIDIEN CUSTOMER SUPPORT ENGINEER (CSE) INSPECTED THE DEVICE AND REPLACED THE GRAPHICAL USER INTERFACE (GUI) AND BACKLIGHT INVERTER PCB. THE UNIT PASSED EXTENDED SELF-TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166527 840 VENTILATOR VENTIALTOR CBK COVIDIEN, FORMERLY NELL 840

    Patients

    Seq Age Sex Outcome Treatment
    1