BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAQUET CARDIOVASCULAR, LLC

    MDR report key: 2288067 · Received September 28, 2011

    Report

    Report Number
    MW5022556
    Event Type
    Malfunction
    Date Received
    September 28, 2011
    Date of Event
    September 3, 2011
    Report Date
    September 27, 2011
    Manufacturer
    MAQUET
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE EQUIPMENT WAS IN USE AND WORKING WELL. AFTER APPROXIMATELY 45 MINUTES, IT WAS REMOVED FROM THE PATIENT'S LEG AND BEGAN SMOKING. DUE TO THE SMOKING, THE EQUIPMENT WAS REMOVED FROM THE FIELD AND REPLACED WITH A NEW ONE. THE GUIDANT COAGULATION CORD WAS ALSO REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAQUET CARDIOVASCULAR, LLC VASOVIEW HEMOPRO GEI MAQUET VH 3000 UNKNOWN
    2 MAQUET CARDIOVASCULAR, LLC VASOVIEW HEMOPRO GEI MAQUET VH3010 UNKNOWN
    3 MAQUET CARDIOVASCULAR, LLC VASOVIEW HEMOPRO GEI MAQUET VH3030 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR