BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHECK O2 PLUS OXYGEN ANALYZER 9153653302

    MDR report key: 4324377 · Received December 12, 2014

    Report

    Report Number
    1531186-2014-06189
    Event Type
    Malfunction
    Date Received
    December 12, 2014
    Report Date
    November 18, 2014
    Manufacturer
    MAXTEC INC.
    Product Code
    CCL
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    GA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    THE DEALER STATES THAT HE'S GETTING A E07 ERROR WHICH IS OUTSIDE OF OPERATING TEMPERATURE BEFORE USE. HE IS IN A 72 DEGREE TEMP WHEN TRYING TO USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    810328 CHECK O2 PLUS OXYGEN ANALYZER 9153653302 ANALYZER, GAS, OXYGEN, GASEOUS-PHASE CCL MAXTEC INC. IRC450

    Patients

    Seq Age Sex Outcome Treatment
    1 Other