BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLURA XPER FD20

    MDR report key: 1971744 · Received December 30, 2010

    Report

    Report Number
    3003768277-2010-00415
    Event Type
    Malfunction
    Date Received
    December 30, 2010
    Date of Event
    December 17, 2010
    Report Date
    December 17, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    IZI
    PMA / PMN Number
    K031333
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION METHOD/RESULTS/CONCLUSIONS: THE INVESTIGATION IS STILL ONGOING ON THIS EVENT. WHEN THE INVESTIGATION IS COMPLETED A FOLLOW-UP REPORT WILL BE SENT TO THE FDA.

    Description of Event or Problem · 1

    THIS X-RAY SYSTEM HAS FLICKERING FLUORO IMAGES. THE INITIAL SYSTEM TROUBLE SHOOTING HAS DETERMINED IT TO BE DUE TO A POSSIBLE CAUSE THAT IS LINKED TO EITHER THE TANK OR THE TUBE. A DEFECT IN EITHER PART MIGHT LEAD TO LOSS OF IMAGING DURING A CRITICAL PHASE IN AN INTERVENTIONAL SITUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALLURA XPER FD20 IZI (SYSTEM, X-RAY ANGIOGRAPHIC) IZI PHILIPS MEDICAL SYSTEMS 722006 NA

    Patients

    Seq Age Sex Outcome Treatment
    1