BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLURA XPER FD10

    MDR report key: 2201407 · Received August 4, 2011

    Report

    Report Number
    3003768277-2011-00449
    Event Type
    Malfunction
    Date Received
    August 4, 2011
    Report Date
    July 8, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    IZI
    PMA / PMN Number
    K031333
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INVESTIGATION IS STILL ONGOING ON THIS EVENT. WHEN THE INVESTIGATION IS COMPLETED, A F/U REPORT WILL BE SENT TO THE FDA.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE MACHINE STOPS AND SWITCHED OFF AT THE END OF A PROCEDURE WITH A PT. THE DOCTOR JUST MADE THE LAST RUN. THE PT DID NOT SUFFER ANY INJURY AS A RESULT OF THIS EVENT.

    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