BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLURA XPER FD10

    MDR report key: 3200936 · Received May 30, 2013

    Report

    Report Number
    3200936
    Event Type
    Malfunction
    Date Received
    May 30, 2013
    Date of Event
    May 6, 2013
    Report Date
    May 3, 2013
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    IZI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN, US
    Reporter Occupation
    RISK MANAGER

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240115 ALLURA XPER FD10 SYSTEM, X-RAY, ANGIOGRAPHIC IZI PHILIPS HEALTHCARE 722003 *

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR