BEUDAMED
    FDA Adverse Event Other Summary report: N

    EASY CAP II CO2 DETECTOR

    MDR report key: 1616566 · Received February 19, 2010

    Report

    Report Number
    2936999-2010-00366
    Event Type
    Other
    Date Received
    February 19, 2010
    Date of Event
    January 3, 2010
    Report Date
    January 21, 2010
    Manufacturer
    COVIDIEN/FORMERLY TYCO HEALTHCARE
    Product Code
    CCK
    PMA / PMN Number
    K944400
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ATTEMPTS HAVE BEEN MADE TO CONTACT THE REPORTER FOR MORE INFO WITH NO SUCCESS. IT IS UNK WHAT THE INITIAL COLOR WAS OUT OF THE PACKAGE; HOW LONG THE EASY CAP II WAS IN USE FOR; IF CONFIRMED SIX BREATH CYCLES. STANDARD CLINICAL ASSESSMENT SHOULD BE USED TO CONFIRM PROPER POSITION OF THE ENDOTRACHEAL TUBE WITHIN THE TRACHEA.

    Description of Event or Problem · 1

    RECEIVED MEDWATCH (B)(6) ON 01/21/2010 STATING THAT EASY CAP II CO2 DETECTOR DID NOT CHANGE COLOR TO INDICATE PROPER VENTILATION OF PT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EASY CAP II CO2 DETECTOR CO2 DETECTOR CCK COVIDIEN/FORMERLY TYCO HEALTHCARE 7334108

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR