BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW 6 PRO

    MDR report key: 3960098 · Received June 23, 2014

    Report

    Report Number
    2242352-2014-00700
    Event Type
    Malfunction
    Date Received
    June 23, 2014
    Date of Event
    May 27, 2014
    Report Date
    May 28, 2014
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    GEI
    PMA / PMN Number
    K091733
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SINCE THE DEVICE IS NOT AVAILABLE TO BE RETURNED TO US, A TECHNICAL EVALUATION CANNOT BE PERFORMED. PER OUR STANDARD SOP'S, ALL EVENTS ARE TRACKED AND TRENDED TO DETERMINE WHETHER OR NOT ANY TRENDS DEVELOP. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE LAST 3 LOTS SHIPPED TO THE ACCOUNT PRIOR TO THE AWARE DATE. THERE WAS NO NONCONFORMANCE RECORDED IN THE LOT HISTORY. (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THERE WAS NO POWER TO THE BISECTOR ON THE VASOVIEW 6 PRO. THE CORD AND DEVICE WERE SWAPPED OUT. THE HOSPITAL IS UNSURE WHICH ONE CORRECTED THE ISSUE. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    364777 VASOVIEW 6 PRO ENDOSCOPIC VESSEL HARVESTING GEI MAQUET CARDIOVASCULAR, LLC VH-2400

    Patients

    Seq Age Sex Outcome Treatment
    1