BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLURA XPER FD20

    MDR report key: 2043375 · Received February 25, 2011

    Report

    Report Number
    3003768277-2011-00008
    Event Type
    Malfunction
    Date Received
    February 25, 2011
    Report Date
    December 10, 2010
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    IZI
    PMA / PMN Number
    K033737
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INVESTIGATION IS STILL ONGOING ON THIS EVENT. WHEN THE INVESTIGATION IS COMPLETED A FOLLOW-UP REPORT WILL BE SENT TO THE FDA (B)(6) 2011.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED WE HAVE DELIVERED INNOVA SYSTEMS WITH AN APPROVED PRODUCT DEVIATION WHERE IT IS POSSIBLE THAT THERE IS A SYSTEM HANGS UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALLURA XPER FD20 IZI, MBQ IZI PHILIPS HEALTHCARE 722012

    Patients

    Seq Age Sex Outcome Treatment
    1