BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEDICAP

    MDR report key: 2613927 · Received June 5, 2012

    Report

    Report Number
    MW5025703
    Event Type
    Malfunction
    Date Received
    June 5, 2012
    Report Date
    June 5, 2012
    Manufacturer
    NELLCOR
    Product Code
    CCK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PEDICAP CO2 DETECTORS CAME OUT OF THE PACKAGE ALREADY PARTIALLY YELLOW AND DO NOT CHANGE COLOR. PACKAGES APPEAR TO BE INTACT. I HAVE 3 THAT WILL GET SENT BACK TO THE COMPANY. LOT #S 1329266, 2033000, 1318128.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PEDICAP CO2 DETECTOR CCK NELLCOR PEDI-CAP 1329266
    2 PEDICAP CO2 DETECTOR CCK NELLCOR PEDI-CAP 2033000
    3 PEDICAP CO2 DETECTOR CCK NELLCOR PEDI-CAP 1318128

    Patients

    Seq Age Sex Outcome Treatment
    1