BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPNOPROBE

    MDR report key: 541811 · Received September 2, 2004

    Report

    Report Number
    2936999-2004-00004
    Event Type
    Death
    Date Received
    September 2, 2004
    Report Date
    September 2, 2004
    Manufacturer
    NELLCOR
    Product Code
    CCK
    Removal / Correction Number
    Z141404
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    BACTERIAL PRESENCE WAS DISCOVERED IN NICU AND SENSOR IS SUSPECT FOR POSSIBLE SOURCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPNOPROBE SUBLINGUAL SENSOR, USE W/N80 MONITOR CCK NELLCOR * SS04149085

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death