BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO EVH SYSTEM

    MDR report key: 2180694 · Received July 7, 2011

    Report

    Report Number
    2242352-2011-00931
    Event Type
    Malfunction
    Date Received
    July 7, 2011
    Report Date
    June 14, 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
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WILL REPORTEDLY NOT BE RETURNED TO MAQUET CARDIAC SURGERY FOR INVESTIGATION. INTERNAL FILE NUMBER - (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VESSEL HARVESTING PROCEDURE, THE VASOVIEW HEMOPRO CABLE WAS REPORTED TO BE BAD. THEY TESTED AT THE BEGINNING OF THE CASE, AND IT WOULDN'T ACTIVATE, THEY CHANGED CABLES AND IT WORKED. THE NUMBER OF USES FOR THE CABLE WAS UNK AS WAS THE EVENT DATE. THERE WERE NO PT EFFECTS. THE PRODUCT IS NOT RETURNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VASOVIEW HEMOPRO EVH SYSTEM DC EXTENSION CABLE GEI MAQUET CARDIOVASCULAR, LLC VH-3030 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA