BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 3802348 · Received February 21, 2014

    Report

    Report Number
    8020893-2014-00450
    Event Type
    Malfunction
    Date Received
    February 21, 2014
    Date of Event
    January 23, 2014
    Report Date
    January 24, 2014
    Manufacturer
    COVIDIEN, FORMERLY NELLCOR
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CSE INSPECTED THE DEVICE AND CONFIRMED AN ERROR CODE IN THE MEMORY LOG RELEVANT TO THE MALFUNCTION. THE CSE REPLACED THE BDU PRINTED CIRCUIT BOARD (PCB). THE CSE PERFORMED EXTENDED SELF-TESTING ON THE DEVICE AND ALL TESTS PASSED. (B)(4).

    Description of Event or Problem · 1

    DURING THE MAINTENANCE OF AN 840 VENTILATOR, THE COVIDIEN CUSTOMER SUPPORT ENGINEER (CSE) NOTICED THAT THE VENTILATOR HAD A LOSS OF COMMUNICATION BETWEEN THE GRAPHIC USER INTERFACE (GUI) AND THE BREATH DELIVERY UNIT(BDU). THE DEVICE WAS NOT IN USE ON A PATIENT WHEN THE MALFUNCTION WAS NOTICED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    109002 840 VENTILATOR CBK COVIDIEN, FORMERLY NELLCOR 840

    Patients

    Seq Age Sex Outcome Treatment
    1