BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRIS ALLURA 9 (BIPLANE)

    MDR report key: 2012352 · Received February 1, 2011

    Report

    Report Number
    3003768277-2011-00081
    Event Type
    Malfunction
    Date Received
    February 1, 2011
    Report Date
    January 4, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    IZI
    PMA / PMN Number
    K002016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INVESTIGATION REPORTED THAT AFTER REPAIR OF THE VIDEO PROCESSING UNIT (VISUB) AND CHANGING OF DISK AND SOME BOARDS THE PROBLEM WAS SOLVED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED NO IMAGE DUE TO VIDEO PROCESSING UNIT FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTEGRIS ALLURA 9 (BIPLANE) IZI PHILIPS HEALTHCARE 722021

    Patients

    Seq Age Sex Outcome Treatment
    1