BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO 2 EVH SYSTEM

    MDR report key: 2093280 · Received April 14, 2011

    Report

    Report Number
    2242352-2011-00342
    Event Type
    Malfunction
    Date Received
    April 14, 2011
    Date of Event
    March 9, 2011
    Report Date
    March 16, 2011
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    GEI
    PMA / PMN Number
    K101274
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WILL REPORTEDLY NOT BE RETURNED TO (B)(4) FOR INVESTIGATION. THE LOT NUMBER COULD NOT BE OBTAINED, SO A LOT HISTORY RECORD REVIEW COULD NOT BE PERFORMED. (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VESSEL HARVESTING PROCEDURE, THE VASOVIEW HEMOPRO 2 TESTED FINE, BUT WHEN PUT IN THE TUNNEL IT WAS SMOKING, HAZY, HAD A BURNING SMELL, AND WAS HOT THE WHOLE TIME. THIS OCCURRED AFTER A FEW ACTIVATIONS, AND THE TOGGLE HAD BEEN RELEASED. A NEW UNIT WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PT EFFECTS. THE PRODUCT WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VASOVIEW HEMOPRO 2 EVH SYSTEM ENDOSCOPIC VESSEL HARVESTING SYSTEM GEI MAQUET CARDIOVASCULAR, LLC VH-4000 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA