BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRIS ALLURA 9 (BIPLANE)

    MDR report key: 2001574 · Received January 26, 2011

    Report

    Report Number
    3003768277-2011-00045
    Event Type
    Malfunction
    Date Received
    January 26, 2011
    Report Date
    December 28, 2010
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    IZI
    PMA / PMN Number
    K002016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INVESTIGATION IS STILL ONGOING ON THIS EVENT. WHEN INVESTIGATION IS COMPLETED, A FOLLOW-UP REPORT WILL BE SENT TO THE FDA BY (B)(4) 2011.

    Description of Event or Problem · 1

    SYSTEM EXCEED THE 10 R/MIN.

    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