BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO EVH SYSTEM

    MDR report key: 1932191 · Received December 14, 2010

    Report

    Report Number
    2242352-2010-03586
    Event Type
    Malfunction
    Date Received
    December 14, 2010
    Date of Event
    November 11, 2010
    Report Date
    November 15, 2010
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    GEI
    PMA / PMN Number
    K052274
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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. INTERNAL FILE NUMBER - (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE DEVICE OVERHEATED DURING THE TESTING PRIOR TO CASE BEING STARTED. THERE WERE NO PT EFFECTS AND THE CASE WAS DONE USING A REPLACEMENT UNIT. THE PRODUCT WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VASOVIEW HEMOPRO EVH SYSTEM ENDOSCOPIC VESSEL HARVESTIGN SYSTEM GEI MAQUET CARDIOVASCULAR, LLC VH-3000 25019152

    Patients

    Seq Age Sex Outcome Treatment
    1 NA