BEUDAMED
    FDA Adverse Event Other Summary report: N

    MICROSTREAM O2/CO2 ORAL NASAL FILTERLINE

    MDR report key: 3935927 · Received June 19, 2014

    Report

    Report Number
    8044004-2014-00009
    Event Type
    Other
    Date Received
    June 19, 2014
    Report Date
    May 21, 2014
    Manufacturer
    COVIDIEN
    Product Code
    CCK
    PMA / PMN Number
    K011536
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER CHANGED THE POSITION OF THE SAMPLING LINE AND THE INTERFERENCE DISAPPEARED. NOTE THAT THE USER MANUALS FOR BOTH CAPNOGRAPHS AND SAMPLING LINES CAUTION THE USER NOT TO USE THE SAMPLING LINES WHICH INCLUDE NAFION DURING MRI SCANNING. (B)(4).

    Description of Event or Problem · 1

    COVIDIEN RECEIVED A REPORT THAT THE SMART CAPNOLINE H O2, A SAMPLING LINE, USED DURING MAGNETIC RESONANCE IMAGING (MRI) CAUSED INTERFERENCE ON THE SCAN. THERE WAS NO HARM OR DELAYED TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    362145 MICROSTREAM O2/CO2 ORAL NASAL FILTERLINE SMART CAPNOLINE H O2 CCK COVIDIEN Q1306016

    Patients

    Seq Age Sex Outcome Treatment
    1