BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NELLCOR

    MDR report key: 3151774 · Received June 4, 2013

    Report

    Report Number
    MW5030442
    Event Type
    Malfunction
    Date Received
    June 4, 2013
    Date of Event
    February 14, 2013
    Report Date
    May 24, 2013
    Manufacturer
    TYCO HEALTHCARE GROUP LF - NELLCOR PURITAN BENNETT DIV.
    Product Code
    CCL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PEDI-CAPS DIDN'T TURN COLOR WHEN TRYING TO IDENTIFY IF PT STILL INTUBATED. THIRD ONE USED ON PT DID NOT TURN COLOR INDICATING PT WAS STILL INTUBATED WHEN ENDOTRACHEAL TUBE STILL IN EXACT SAME POSITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    246640 NELLCOR PEDI-CAP CO2 DETECTOR, #1 CCL TYCO HEALTHCARE GROUP LF - NELLCOR PURITAN BENNETT DIV. 0238052

    Patients

    Seq Age Sex Outcome Treatment
    1 1 MO