BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO

    MDR report key: 2842794 · Received November 15, 2012

    Report

    Report Number
    2842794
    Event Type
    Malfunction
    Date Received
    November 15, 2012
    Date of Event
    November 8, 2012
    Report Date
    November 15, 2012
    Manufacturer
    MAQUET CARDIOVASCULAR
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    WHILE TAKING VEIN DURING A CABG PROCEDURE, VASOVIEW HEMOPRO HAD A "C-RING FAILURE" WHICH RESULTED IN HAVING TO OPEN ANOTHER VASOVIEW HEMOPRO DEVICE VH-3000.NOTE: THIS IS THE THIRD EVENT WITH THIS DEVICE SINCE THE BEGINNING OF YEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VASOVIEW HEMOPRO ELECTROSURGICAL, VESSEL HARVESTING SYSTEM GEI MAQUET CARDIOVASCULAR * 25061099

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR NONE KNOWN