BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PEDI-CAP

    MDR report key: 3805824 · Received May 6, 2014

    Report

    Report Number
    MW5036025
    Event Type
    Injury
    Date Received
    May 6, 2014
    Date of Event
    May 4, 2014
    Report Date
    May 5, 2014
    Manufacturer
    NELLCOR
    Product Code
    CCK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    MULTIPLE PEDI-CAPS HAD TO BE UTILIZED TO OBTAIN A PEDICAP THAT WOULD WORK PROPERLY. THE CO2 DETECTOR IS CHANGING COLORS PRIOR TO OR AS THE PACKAGE IS OPENING. IF THE CAPS ARE ALREADY YELLOW, THEY ARE NOT ABLE TO BE USED DURING AN INTUBATION PROCEDURE THAT MUST BE TIMELY WITH TIMELY CONFIRMATION OF PROPER PLACEMENT. WENT THROUGH 5 PEDI CAPS DURING AN INTUBATION ATTEMPT BEFORE THE PROVIDER FOUND ONE THAT DIDN'T CHANGE COLORS PRIOR TO PLACEMENT ON THE ETT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271154 PEDI-CAP NONE CCK NELLCOR 133600084X
    271155 PEDI-CAP CCK NELLCOR 133600084X
    271156 PEDI-CAP CCK NELLCOR 133600084X
    271157 PEDI-CAP CCK NELLCOR 133600084X
    271158 PEDI-CAP CCK NELLCOR 133600084X

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening