BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 2915308 · Received January 9, 2013

    Report

    Report Number
    8020893-2013-00054
    Event Type
    Malfunction
    Date Received
    January 9, 2013
    Date of Event
    November 16, 2012
    Report Date
    November 16, 2012
    Manufacturer
    COVIDIEN, FORMERLY NELLCOR PURITAN
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE COVIDIEN CUSTOMER SUPPORT ENGINEER (CSE) REPORTED THAT AN 840 VENTILATOR HAD A BLANK SCREEN. NO PT INVOLVEMENT. THE CSE INSPECTED THE DEVICE AND REPLACED THE BACKLIGHT INVERTER PCB. THE UNIT PASSED EXTENDED SELF-TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12455 840 VENTILATOR VENTILATOR CBK COVIDIEN, FORMERLY NELLCOR PURITAN 840

    Patients

    Seq Age Sex Outcome Treatment
    1