BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLURA XPER FD20

    MDR report key: 2020572 · Received February 10, 2011

    Report

    Report Number
    3003768277-2011-00138
    Event Type
    Malfunction
    Date Received
    February 10, 2011
    Report Date
    January 12, 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). THIS EVENT IS STILL UNDER INVESTIGATION. THE FOLLOW-UP REPORT WILL BE SENT BY (B)(4) 2011.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT WITH A DETECTOR FORMAT, THE DOSE RATE IS OUTSIDE TOLERANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALLURA XPER FD20 IZI, MBQ IZI PHILIPS HEALTHCARE 722006

    Patients

    Seq Age Sex Outcome Treatment
    1