BEUDAMED
    FDA Adverse Event Death Summary report: N

    PORTEX CO2 CLIP

    MDR report key: 676319 · Received November 9, 2005

    Report

    Report Number
    MW1037183
    Event Type
    Death
    Date Received
    November 9, 2005
    Date of Event
    November 8, 2005
    Report Date
    November 9, 2005
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    CCK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    LA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING INTUBATION, PORTEX C02 DETECTOR DEVICE FAILED. DEVICE SHOULD CHANGE COLOR WHEN MEASURING CO2 EXHALED AFTER PLACEMENT OF ET TUBE. DEVICE DID NOT CHANGE COLOR. PLACEMENT CONFIRMED THRU OTHER MEASURES. THIS PROBLEM PREVIOUSLY REPORTED IN 08/2005 WITH LOT #P04-0024. REPS NOTIFIED, PRODUCT REPLACED. THIS IS A NEW OCCURRENCE WITH LOT #. HOWEVER, PACKAGING WAS NOT RETAINED SO CANNOT VERIFY LOT#.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PORTEX CO2 CLIP CO2 DETECTOR CCK SMITHS MEDICAL ASD, INC. 8530-C *

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Death