BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPNOPROBE

    MDR report key: 548165 · Received October 13, 2004

    Report

    Report Number
    2936999-2004-00037
    Event Type
    Death
    Date Received
    October 13, 2004
    Date of Event
    October 1, 2004
    Report Date
    October 13, 2004
    Manufacturer
    RESPIRATORY PLEASANTON
    Product Code
    CCK
    Removal / Correction Number
    Z141404
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CORONER REPORTED SUSPECTED DEATH FROM BURKHOLDERIA CEPACIA. IT WAS REPORTED THAT THE DECEASED RECEIVED A LETTER OF NOTIFICATION FROM HOSPITAL ADVISING THAT THE DECEASED MAY HAVE HAD EXPOSURE TO SLS1 SENSOR DURING A PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPNOPROBE SLS-1 SUBLINGUAL SENSOR CCK RESPIRATORY PLEASANTON SLS1 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Death