BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 3901815 · Received May 8, 2014

    Report

    Report Number
    8020893-2014-01105
    Event Type
    Malfunction
    Date Received
    May 8, 2014
    Date of Event
    March 29, 2014
    Report Date
    April 11, 2014
    Manufacturer
    COVIDIEN , FORMERLY NELLC
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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 GRAPHICAL USER INTERFACE (GUI) TO THE BREATH DELIVERY (BD) CABLE. 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 WAS RECEIVED FROM THE USA WITH INFORMATION STATING THAT AN 840 VENTILATOR HAD A LOSS OF COMMUNICATION BETWEEN THE GRAPHIC USER INTERFACE (GUI) AND THE BREATH DELIVERY (BD). 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
    280155 840 VENTILATOR CBK COVIDIEN , FORMERLY NELLC 840

    Patients

    Seq Age Sex Outcome Treatment
    1