BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLURA XPER FD10

    MDR report key: 2039179 · Received February 22, 2011

    Report

    Report Number
    3003768277-2011-00213
    Event Type
    Malfunction
    Date Received
    February 22, 2011
    Report Date
    January 25, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    IZI
    PMA / PMN Number
    K031333
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS EVENT IS STILL UNDER INVESTIGATION. THE F/U REPORT WILL BE SENT BY 04/23/2011.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS A FAULT WITH ALLURA EQUIPMENT. IT SENDS AN ERROR MESSAGE AND THE FLUOROSCOPY IS NOT ENABLED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALLURA XPER FD10 IZI, MBQ IZI PHILIPS HEALTHCARE 722003

    Patients

    Seq Age Sex Outcome Treatment
    1