BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW 7 XB

    MDR report key: 2160332 · Received May 16, 2011

    Report

    Report Number
    2242352-2011-00449
    Event Type
    Malfunction
    Date Received
    May 16, 2011
    Date of Event
    April 20, 2011
    Report Date
    April 21, 2011
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    GEI
    PMA / PMN Number
    K041981
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD CODE: THE DEVICE WILL REPORTEDLY NOT BE RETURNED TO MAQUET CARDIAC SURGERY FOR INVESTIGATION. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE PRODUCT. THERE WAS NO NONCONFORMANCE WHICH COULD HAVE CONTRIBUTED TO THIS FAILURE MODE. (B)(4).

    Description of Event or Problem · 1

    THE HOSP REPORTED THAT DURING AN ENDOSCOPIC VESSEL HARVESTING PROCEDURE, THE VASOVIEW 7 BISECTOR WAS NOT WORKING, HAD NO POWER. THE CORD WAS CHANGED, BUT IT STILL WOULD NOT WORK. ANOTHER UNIT WAS USED TO COMPLETE THE PROCEDURE. THE KITS WERE USED AT A SETTING OF 30. THERE WERE NO PT EFFECTS. THE PRODUCT WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VASOVIEW 7 XB VASOVIEW BISECTOR GEI MAQUET CARDIOVASCULAR, LLC VH-3200 25027789

    Patients

    Seq Age Sex Outcome Treatment
    1 NA