BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO EVH SYSTEM

    MDR report key: 1970916 · Received January 5, 2011

    Report

    Report Number
    2242352-2010-03830
    Event Type
    Malfunction
    Date Received
    January 5, 2011
    Date of Event
    December 7, 2010
    Report Date
    December 7, 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
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO MAQUET CARDIAC SURGERY FOR INVESTIGATION. WE WILL CONTINUE PURSUING THE DEVICE BEING RETURNED BY THE CUSTOMER. A LOT HISTORY RECORD REVIEW WAS PERFORMED ON THE REPORTED LOT NUMBER, AND THERE WERE NO NON-CONFORMITIES WHICH COULD HAVE CONTRIBUTED TO THE REPORTED FAILURE MODE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE DEVICE IS RECEIVED AND THE INVESTIGATION IS COMPLETED. INTERNAL FILE NUMBER - (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VESSEL HARVESTING PROCEDURE, THE VASOVIEW HEMOPRO WOULD NOT ACTIVATE DURING THE PRE-TEST. A NEW KIT WAS USED TO COMPLETE THE CASE WITHOUT INCIDENT OR HARM TO THE PATIENT. THE PRODUCT IS RETURNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VASOVIEW HEMOPRO EVH SYSTEM ENDOSCOPIC VESSEL HARVESTING SYSTEM GEI MAQUET CARDIOVASCULAR, LLC VH-3000 25022676

    Patients

    Seq Age Sex Outcome Treatment
    1 NA