BEUDAMED
    FDA Adverse Event Other Summary report: N

    EASY CAP II CO2 DETECTOR

    MDR report key: 1278446 · Received December 31, 2008

    Report

    Report Number
    2936999-2008-00648
    Event Type
    Other
    Date Received
    December 31, 2008
    Date of Event
    December 1, 2008
    Report Date
    December 19, 2008
    Manufacturer
    COVIDIEN, FORMERLY TYCO HEALTHCARE
    Product Code
    CCK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN REQUESTED FOR EVAL, IT HAS NOT BEEN REC'D. THE EASYCAP II WORKED AS EXPECTED, THE CALCIUM OXIDE PACKET IS THE ISSUE. THE REPORTER SPOKE TO MFR OF THE CALCIUM OXIDE PACKET - SUD-CHEMI - STATES PACKET WILL GENERATE HEAT ON CONTACT WITH H2O OR MOISTURE. THIS RISK IS INDICATED ON THE PACKAGING.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN THAT DURING A CODE BLUE, THE CALCIUM OXIDE FRESHNESS PACKET THAT IS PACKED IN THE EASYCAP II FOIL POUCH FELL OUT OF THE POUCH AND CAME IN CONTACT WITH FLUID WHICH AS A RESULT CHEMICALLY REACTED AND BURNED THE PT. PT WAS STABILIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EASY CAP II CO2 DETECTOR CO2 DETECTOR CCK COVIDIEN, FORMERLY TYCO HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1