BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 4221894 · Received November 3, 2014

    Report

    Report Number
    8020893-2014-02423
    Event Type
    Malfunction
    Date Received
    November 3, 2014
    Date of Event
    September 24, 2014
    Report Date
    October 28, 2014
    Manufacturer
    COVIDIEN
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COVIDIEN CUSTOMER SUPPORT ENGINEER (CSE) INSPECTED THE DEVICE AND SMELLED SMOKE FROM THE GRAPHIC USER INTERFACE (GUI) AND NOTICED A BURNT CONNECTION BETWEEN THE LOWER BACKLIGHT INVERTER PRINTED CIRCUIT BOARD (PCB) AND THE LOWER LIQUID CRYSTAL DISPLAY (LCD). THE CSE REPLACED THE LOWER BACKLIGHT INVERTER PCB, THE LOWER LCD AND PERFORMED EXTENDED SELF-TESTING ON THE DEVICE AND ALL TESTS PASSED. (B)(4).

    Description of Event or Problem · 1

    COVIDIEN RECEIVED INFORMATION STATING THAT THE LOWER DISPLAY ON AN 840 VENTILATOR WAS FAULTY. 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
    700916 840 VENTILATOR CONTINUOUS VENTILATOR CBK COVIDIEN 840

    Patients

    Seq Age Sex Outcome Treatment
    1