BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHECK O2 PLUS OXYGEN ANALYZER 9153653302

    MDR report key: 4406848 · Received January 12, 2015

    Report

    Report Number
    1531186-2015-00162
    Event Type
    Malfunction
    Date Received
    January 12, 2015
    Report Date
    December 22, 2014
    Manufacturer
    MAXTEC INC.
    Product Code
    CCL
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    THE DEALER STATES THAT THE DEVICE IS NO LONGER READING FLOW OR O2 CONCENTRATION LEVELS. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26276 CHECK O2 PLUS OXYGEN ANALYZER 9153653302 ANALYZER, GAS, OXYGEN, GASEOUS-PHASE CCL MAXTEC INC. IRC450

    Patients

    Seq Age Sex Outcome Treatment
    1 Other