BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLURA XPER FD10C

    MDR report key: 2060812 · Received March 11, 2011

    Report

    Report Number
    3003768277-2011-00271
    Event Type
    Malfunction
    Date Received
    March 11, 2011
    Report Date
    February 15, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    IZI
    PMA / PMN Number
    K031333
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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

    THE CUSTOMER REPORTS THAT ONLY DOWNLOADING IS POSSIBLE. NO MORE FILMING, FILMING WAS INTERRUPTED DURING THE EXAMINATION AND CAN NO LONGER BE STARTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALLURA XPER FD10C IZI, MBQ IZI PHILIPS HEALTHCARE 722001

    Patients

    Seq Age Sex Outcome Treatment
    1