BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASO VIEW MEMOPRO

    MDR report key: 3983281 · Received July 3, 2014

    Report

    Report Number
    2242352-2014-00738
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Date of Event
    June 5, 2014
    Report Date
    June 5, 2014
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    DXC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT YET BEEN RETURNED TO MAQUET CARDIAC SURGERY FOR EVALUATION. WE ARE FOLLOWING UP WITH THE CUSTOMER FOR THE RETURN OF THE DEVICE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED. SPECIFIC ACTIONS FOR THIS FAILURE MODE ARE BEING MANAGED AND DOCUMENTED IN THE MAQUET CAPA SYSTEM. (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE BTT WOULD NOT INFLATE ON THE VASO VIEW HEMOPRO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    392035 VASO VIEW MEMOPRO ENDOSCOPIC VESSEL HARVESTING DXC MAQUET CARDIOVASCULAR, LLC VH-3000 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI