BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVOXIMETER 1000E

    MDR report key: 2132507 · Received June 10, 2011

    Report

    Report Number
    2132507
    Event Type
    Malfunction
    Date Received
    June 10, 2011
    Date of Event
    May 24, 2011
    Report Date
    May 25, 2011
    Manufacturer
    INTERNATIONAL TECHNIDYNE CORP
    Product Code
    DQA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US

    Narratives

    Description of Event or Problem · 1

    THE ITC INTERNATIONAL TECHNIDYNE CORP AVOXIMETER 1000E COMES WITH 2 QC QUALITY CONTROL OPTICAL FILTERS THAT ARE SERIAL NUMBER SPECIFIC: 1 ORANGE AND 1 YELLOW. THE DEVICE DOES NOT COME WITH A HOLDER FOR THESE QC FILTERS. IN OUR CATH CATHETERIZATION LAB WE HAVE 4 UNITS AND THEY ARE STORED IN A GENERAL USE AREA BECAUSE WE HAVE 11 CATH LAB ROOMS. TO PREVENT THE STAFF MIXING UP THE QC FILTERS, BIOMED BIOMEDICAL ENGINEERING HAD TO CREATE A HOLDER ON THE SIDE OF EACH DEVICE SO THE SERIAL SPECIFIC QC FILTERS STAY WITH THE INTENDED UNIT. EACH DAY THE UNITS MUST BE QUALITY CONTROLLED AND/OR WHENEVER THE PERFORMANCE OF THE DEVICE IS IN QUESTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AVOXIMETER 1000E WHOLE BLOOD OXIMETER DQA INTERNATIONAL TECHNIDYNE CORP 1000E *

    Patients

    Seq Age Sex Outcome Treatment
    1 *