BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRIS ALLURA 15-12 (MONO)

    MDR report key: 2021413 · Received February 8, 2011

    Report

    Report Number
    3003768277-2011-00132
    Event Type
    Malfunction
    Date Received
    February 8, 2011
    Report Date
    January 11, 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). THIS EVENT IS STILL UNDER INVESTIGATION. THE FOLLOW-UP REPORT WILL BE SENT BY (B)(4) 2011.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS THAT THE COLLIMATOR IS SPORADICALLY NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTEGRIS ALLURA 15-12 (MONO) IZI PHILIPS HEALTHCARE 722043

    Patients

    Seq Age Sex Outcome Treatment
    1