BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYCAP II

    MDR report key: 3894541 · Received April 25, 2014

    Report

    Report Number
    2936999-2014-00370
    Event Type
    Malfunction
    Date Received
    April 25, 2014
    Date of Event
    March 27, 2014
    Report Date
    March 27, 2014
    Manufacturer
    COVIDIEN
    Product Code
    CCK
    PMA / PMN Number
    K894053
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED PRODUCT EASYCAP II CO2 DETECTOR WAS NOT RETURNED FOR INVESTIGATION. THEREFORE, AN INVESTIGATION ON THE ACTUAL DEVICE CANNOT BE PERFORMED TO CONFIRM THE REPORTED ISSUE. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER CONFIRMING THAT THE PRODUCT WAS PRODUCED ACCORDING TO QUALITY REQUIREMENTS AND RELEASED PER ESTABLISHED PROCEDURES. NONCONFORMANCE (CAPA) INVESTIGATION IS CURRENTLY OPEN TO ADDRESS THE REPORTED FAILURE. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN THAT DURING INTUBATION THE EASY CAP DETECTOR DID NOT CHANGE COLOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252744 EASYCAP II ADULT END TIDAL CO2 DETECTOR CCK COVIDIEN 2114182

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR