BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AV400

    MDR report key: 7713508 · Received July 24, 2018

    Report

    Report Number
    7713508
    Event Type
    Malfunction
    Date Received
    July 24, 2018
    Date of Event
    July 11, 2018
    Report Date
    July 20, 2018
    Manufacturer
    ACCUVEIN, INC.
    Product Code
    KZA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    THIS WAS A MALFUNCTION OF THE ACCUVEIN DEVICE WHERE THE SCREEN HAD ONLY SHOWED A PARTIAL DISPLAY. WE HAVE SEEN THESE ISSUES IN THE PAST, BUT THE RETURN AND REPLACE POLICY OF ACCUVEIN HAS ALLOWED FOR TIMELY RESOLUTION TO ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    555953 AV400 DEVICE, VEIN LOCATION, LIQUID CRYSTAL KZA ACCUVEIN, INC. AV 400

    Patients

    Seq Age Sex Outcome Treatment
    1