BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRIS H5000C/ALLURA 9C

    MDR report key: 2036699 · Received February 15, 2011

    Report

    Report Number
    3003768277-2011-00169
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Report Date
    January 19, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    IZI
    PMA / PMN Number
    K984545
    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 F/U REPORT WILL BE SENT BY 04/17/2011.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT "THE SYSTEM FROZE DURING THE EXAMINATION AND THEN HAD TO BE FULLY RESTARTED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTEGRIS H5000C/ALLURA 9C IZI PHILIPS HEALTHCARE 722016

    Patients

    Seq Age Sex Outcome Treatment
    1