BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLURA XPER FD10

    MDR report key: 2153461 · Received June 21, 2011

    Report

    Report Number
    3003768277-2011-00423
    Event Type
    Malfunction
    Date Received
    June 21, 2011
    Report Date
    June 2, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    IZI
    PMA / PMN Number
    K031333
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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

    THE CUSTOMER REPORTED UNABLE TO X-RAY, EXAMINATION TIME WAS EXTENDED AND THE PHYSICIAN COULDN'T DO FLUOROSCOPY AND EXPOSURE DURING EXAMINATION. IT HAPPENS INTERMITTENTLY. THERE WAS NO INJURY REPORTED TO THE PATIENT.

    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