BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLURA XPER FD10

    MDR report key: 2102825 · Received April 12, 2011

    Report

    Report Number
    3003768277-2011-00348
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Report Date
    April 15, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    IZI
    PMA / PMN Number
    K031333
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). WHEN INVESTIGATION IS COMPLETED A F/U REPORT WILL BE SENT TO THE FDA.

    Description of Event or Problem · 1

    SOMETIMES NO X-RAY (NO IMAGE) AVAILABLE BOTH DURING FLUORO AND EXPOSURE. AFTER PRESSING THE FOOT PEDAL SEVERAL TIMES (2-6 TIMES) THE SYSTEM WORKS FINE AGAIN. PROBLEM OCCURS 2 TIMES PER 2-3 DAYS.

    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