BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW 7 XB EVH SYSTEM

    MDR report key: 1864858 · Received September 28, 2010

    Report

    Report Number
    2242352-2010-02961
    Event Type
    Malfunction
    Date Received
    September 28, 2010
    Date of Event
    August 27, 2010
    Report Date
    August 30, 2010
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    GEI
    PMA / PMN Number
    K041981
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO MAQUET CARDIAC SURGERY ON (B)(6), 2010, FOR INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED. INTERNAL FILE NUMBER - (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE BIPOLAR ON THE VASOVIEW 7 XB EVH SYSTEM WAS NOT DELIVERING ENERGY. THEY SWITCHED THE CORD, BUT THE UNIT WOULD STILL NOT POWER UP. A NEW KIT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PT EFFECTS. THE PRODUCT WAS RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VASOVIEW 7 XB EVH SYSTEM BISECTOR GEI MAQUET CARDIOVASCULAR, LLC VH-3200 25013995

    Patients

    Seq Age Sex Outcome Treatment
    1 NA