BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRI-TEK BG-OX CARTRIDGE

    MDR report key: 708133 · Received May 1, 2006

    Report

    Report Number
    3002807968-2006-00025
    Event Type
    Malfunction
    Date Received
    May 1, 2006
    Date of Event
    March 15, 2006
    Report Date
    May 1, 2006
    Manufacturer
    RADIOMETER MEDICAL APS
    Product Code
    JJS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    AIR BUBBLES MAY BE TRAPPED ON OR CLOSE TO THE 02 SENSOR ON SOME CUVETTES. AIR BUBBLES MAY LEAD TO ERRONEOUS PO2 RESULTS WITHOUT QUESTIONING THE RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DRI-TEK BG-OX CARTRIDGE CARTRIDGE FOR NPT7 BLOOD GAS ANALYZER JJS RADIOMETER MEDICAL APS D7120 299

    Patients

    Seq Age Sex Outcome Treatment
    1 *