BEUDAMED
    FDA Adverse Event Death Summary report: N

    NELLCOR PEDI-CAP CO2 DETECTOR

    MDR report key: 1459156 · Received August 28, 2009

    Report

    Report Number
    1459156
    Event Type
    Death
    Date Received
    August 28, 2009
    Date of Event
    August 18, 2009
    Report Date
    August 26, 2009
    Manufacturer
    NELLCOR
    Product Code
    CCK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING A RESUSCITATION ON THIS PT, 5 PEDI-CAP CO2 DETECTORS WERE USED TRYING TO ESTABLISH A PATENT AIRWAY. THE MD COULD NOT GET GOOD AIRFLOW OR COLOR CHANGE, EVEN THOUGH SHE AND SEVERAL OTHER MD'S AND NNP'S COULD CLEARLY SEE THE ETT WAS PASSED THROUGH THE VOCAL CORDS. AFTER THE BABY WAS DECLARED DEAD, IT WAS DISCOVERED THAT WE RECEIVED A VOLUNTARY RECALL NOTICE ON THIS EXACT PRODUCT THAT EXACT SAME DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NELLCOR PEDI-CAP CO2 DETECTOR END TIDAL CO2 DETECTOR CCK NELLCOR 9082377

    Patients

    Seq Age Sex Outcome Treatment
    1 10 DA Death