BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 3831904 · Received March 6, 2014

    Report

    Report Number
    8020893-2014-00548
    Event Type
    Malfunction
    Date Received
    March 6, 2014
    Date of Event
    February 1, 2014
    Report Date
    February 4, 2014
    Manufacturer
    COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT IRELAND
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COVIDIEN CUSTOMER SUPPORT ENGINEER (CSE) VERIFIED THE MALFUNCTION. THE CSE INSPECTED THE DEVICE AND REPLACED THE GRAPHICAL USER INTERFACE (GUI) PRINTED CIRCUIT BOARD (PCB). THE UNIT PASSED ALL TESTING. (B)(4).

    Description of Event or Problem · 1

    A REPORT RECEIVED FROM (B)(6) INDICATES THE DEVICE HAD AN ERRATIC SCREEN AND THE UPPER GRAPHICAL USER INTERFACE LIQUID CRYSTAL DISPLAY (GUI/LCD) HAD VERTICAL LINES ACROSS THE SCREEN. THE EVENT WAS NOTED DURING ROUTINE MAINTENANCE. THERE WAS NO PT IMPACT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135008 840 VENTILATOR CBK, VENTILATOR CBK COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT IRELAND 840

    Patients

    Seq Age Sex Outcome Treatment
    1