BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRIS ALLURA

    MDR report key: 1625937 · Received March 1, 2010

    Report

    Report Number
    3003768277-2010-00033
    Event Type
    Malfunction
    Date Received
    March 1, 2010
    Report Date
    February 5, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    IZI
    PMA / PMN Number
    K002016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD, RESULTS AND CONCLUSIONS EVAL- THE INVESTIGATION IS STILL ONGOING ON THIS EVENT. WHEN THE INVESTIGATION IS COMPLETED, A F/U REPORT WILL BE SENT TO THE FDA.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED UPON NOTIFICATION FROM OUR MFR IN (B)(4), TO SUBMIT THIS EVENT THAT HAPPENED IN (B)(6). PROBLEM: THE PT WAS HAVING AN X-RAY PROCEDURE. THE X-RAY SYSTEM DURING THIS VASCULAR TREATMENT SUDDENLY COULD NOT PRODUCE X-RAY. THE PT WAS NOT INJURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTEGRIS ALLURA IZI (ANGIOGRAPHIC X-RAY SYSTEM) IZI PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. 722044 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA