BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLURA XPER FD20 BIPLANE

    MDR report key: 1994299 · Received January 14, 2011

    Report

    Report Number
    3003768277-2011-00011
    Event Type
    Malfunction
    Date Received
    January 14, 2011
    Report Date
    December 10, 2010
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    IZI
    PMA / PMN Number
    K033737
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS EVENT IS STILL UNDER INVESTIGATION. THE FOLLOW-UP REPORT WILL BE SENT BY (B)(4) 2011.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE FLUOROSCOPY SYSTEM WAS INTERMITTENTLY DISPLAYING THE IMAGE. WHEN THE PHYSICIAN PLACES THE CATHETER AT THE EDGE OF THE IMAGE THEY NO LONGER CAN SEE THE CATHETER WHEN THE SMART-MARK OPTION SELECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALLURA XPER FD20 BIPLANE IZI, KPR IZI PHILIPS HEALTHCARE 722008

    Patients

    Seq Age Sex Outcome Treatment
    1