BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRIS ALLURA 9

    MDR report key: 2211973 · Received August 10, 2011

    Report

    Report Number
    3003768277-2011-00489
    Event Type
    Malfunction
    Date Received
    August 10, 2011
    Report Date
    July 15, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    IZI
    PMA / PMN Number
    K002016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). WHEN INVESTIGATION IS COMPLETED A FOLLOW-UP REPORT WILL BE SENT TO THE FDA.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM CRASHES REPEATEDLY; THERE IS NO FLUOROSCOPY DURING AN EXAMINATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTEGRIS ALLURA 9 IZI PHILIPS HEALTHCARE 722018

    Patients

    Seq Age Sex Outcome Treatment
    1