BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 4221471 · Received November 3, 2014

    Report

    Report Number
    8020893-2014-02429
    Event Type
    Malfunction
    Date Received
    November 3, 2014
    Date of Event
    October 6, 2014
    Report Date
    October 7, 2014
    Manufacturer
    COVIDIEN
    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

    A COVIDIEN CUSTOMER SUPPORT ENGINEER (CSE) EVALUATED THE DEVICE AND VERIFIED THE REPORTED MALFUNCTION. THE CSE REPLACED THE GRAPHICAL USER INTERFACE (GUI) PRINTED CIRCUIT BOARD (PCB) AND UPDATED THE BACKLIGHT INVERTER PCB. THE CSE ALSO UPDATED THE SOFTWARE TO THE LATEST REVISION, AND PERFORMED CALIBRATIONS AND VERIFICATION TESTING. THE VENTILATOR PASSED ALL TESTS AND WAS OPERATING WITHIN MANUFACTURING SPECIFICATIONS. (B)(4).

    Description of Event or Problem · 1

    COVIDIEN RECEIVED INFORMATION STATING THAT THE LOWER GRAPHICAL USER INTERFACE (GUI) DISPLAY ON AN 840 VENTILATOR WAS ERRATIC. THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME OF THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701701 840 VENTILATOR CONTINUOUS VENTILATOR CBK COVIDIEN 840

    Patients

    Seq Age Sex Outcome Treatment
    1