BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 3962770 · Received June 23, 2014

    Report

    Report Number
    8020893-2014-01514
    Event Type
    Malfunction
    Date Received
    June 23, 2014
    Date of Event
    January 1, 2014
    Report Date
    June 2, 2014
    Manufacturer
    COVIDIEN, FORMERLY NELLCO
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COVIDIEN CUSTOMER SUPPORT ENGINEER (CSE) INSPECTED THE DEVICE AND VERIFIED THE MALFUNCTION. THE CSE REPLACED THE GUI CENTRAL PROCESSING UNIT (CPU) PRINTED CIRCUIT BOARD (PCB), BACKLIGHT INVERTER PRINTED CIRCUIT BOARD (PCBS) AND UPGRADED THE DEVICE WITH THE CURRENT SOFTWARE. THE CSE PERFORMED EXTENDED SELF-TESTING ON THE DEVICE AND ALL TESTS PASSED. COVIDIEN REFERENCE: (B)(4).

    Description of Event or Problem · 1

    A REPORT RECEIVED FROM THE USA STATED AN 840 VENTILATOR EXPERIENCED A FAILED GRAPHICAL USER INTERFACE (GUI) CENTRAL PROCESSING UNIT (CPU) WHICH RENDERED THE VENTILATOR INOPERABLE. THOUGH REQUESTED, PT INVOLVEMENT IS UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    364649 840 VENTILATOR CBK COVIDIEN, FORMERLY NELLCO 840

    Patients

    Seq Age Sex Outcome Treatment
    1