BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYZER, GAS, OXYGEN, GASEOUS-PHASE

    MDR report key: 3973373 · Received August 1, 2014

    Report

    Report Number
    9613440-2014-00001
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Report Date
    June 13, 2014
    Manufacturer
    DYNAMIC CONTROLS
    Product Code
    CCL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPON FURTHER REVIEW, IT WAS DETERMINED THAT THE INITIAL REPORT SUBMITTED ON 08/01/2014 FOR MANUFACTURER REPORT # 9613440-2014-00001 WAS NOT A REPORTABLE EVENT. THIS PRODUCT, AN IRC400 HAND HELD ANALYZER, IS NOT A MEDICAL DEVICE. IT IS A TECHNICIAN'S TOOL FOR OXYGEN CONCENTRATORS TO CHECK THE OXYGEN CONCENTRATION, FLOW RATE AND OUTLET PRESSURE. NO MDR NEEDED TO BE FILED.

    Description of Event or Problem · 1

    PER THE DEALER, THE UNIT WILL NOT ANALYZE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450897 ANALYZER, GAS, OXYGEN, GASEOUS-PHASE 868.1720 CCL DYNAMIC CONTROLS IRC400

    Patients

    Seq Age Sex Outcome Treatment
    1 Other