BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHECK O2 PLUS OXYGEN ANALYZER 9153653302

    MDR report key: 4478367 · Received February 3, 2015

    Report

    Report Number
    1531186-2015-00764
    Event Type
    Malfunction
    Date Received
    February 3, 2015
    Date of Event
    January 19, 2015
    Report Date
    January 27, 2015
    Manufacturer
    MAXTEC INC.
    Product Code
    CCL
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    VA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    DEALER STATES THAT THE UNIT WILL READ JUST 0'S, GETS NOTHING ELSE WHEN HOOKED UP TO A CONCENTRATOR. UNIT SHIPPED (B)(4) 2013. (B)(4) PROVIDER STATES NO PROPERTY DAMAGE OR INJURY ALLEGED, PROVIDER STATES THE UNIT IS USED BY HIS DRIVERS TO ANALYZE EQUIPMENT. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77348 CHECK O2 PLUS OXYGEN ANALYZER 9153653302 ANALYZER, GAS, OXYGEN, GASEOUS-PHASE CCL MAXTEC INC. IRC450

    Patients

    Seq Age Sex Outcome Treatment
    1 Other