BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 3823330 · Received February 19, 2014

    Report

    Report Number
    8020893-2014-00407
    Event Type
    Malfunction
    Date Received
    February 19, 2014
    Date of Event
    January 14, 2014
    Report Date
    January 14, 2014
    Manufacturer
    COVIDIEN, FORMERLY NELLCO
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COVIDIEN CUSTOMER SUPPORT ENGINEER (CSE) INSPECTED THE DEVICE AND WAS NOT ABLE TO DUPLICATE THE ALLEGED MALFUNCTION. THE CSE UPGRADED THE SOFTWARE TO THE CURRENT REVISION. THE CSE PERFORMED EXTENDED SELF-TESTING ON THE DEVICE AND ALL TESTS PASSED.

    Description of Event or Problem · 1

    COVIDIEN RECEIVED INFORMATION STATING THAT AN 840 VENTILATOR HAD A LOSS OF COMMUNICATION BETWEEN THE GRAPHIC USER INTERFACE (GUI) AND THE BREATH DELIVER UNIT (BDU). THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME THE MALFUNCTION OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105598 840 VENTILATOR CBK, VENTILATOR, CONTINUOUS, FACILI CBK COVIDIEN, FORMERLY NELLCO 840

    Patients

    Seq Age Sex Outcome Treatment
    1