BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 2980590 · Received February 22, 2013

    Report

    Report Number
    8020893-2013-00426
    Event Type
    Malfunction
    Date Received
    February 22, 2013
    Date of Event
    February 1, 2013
    Report Date
    February 1, 2013
    Manufacturer
    COVIDIEN, FORMERLY NELLCOR
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT AN 840 VENTILATOR HAD AN ERRATIC DISPLAY. THE CUSTOMER REPORTED TO HAVE REPLACED THE GRAPHIC USER INTERFACE CPU PCB. THE UNIT PASSED EXTENDED SELF-TESTING. THE COVIDIEN CUSTOMER SUPPORT ENGINEER (CSE) WAS ONLY AUTHORIZED TO UPLOAD THE SOFTWARE. THE VENTILATOR PASSED ALL TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77533 840 VENTILATOR VENTILATOR CBK COVIDIEN, FORMERLY NELLCOR 840

    Patients

    Seq Age Sex Outcome Treatment
    1