BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRIS ALLURA 15-12 (MONO)

    MDR report key: 2040274 · Received February 15, 2011

    Report

    Report Number
    3003768277-2011-00267
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Report Date
    February 14, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    IZI
    PMA / PMN Number
    K002016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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 STATES THAT: "DURING AN EXAMINATION, THE TABLE SHUT DOWN IN AN ILLED TIMED MANNER, NO MORE IMAGES ON THE SCREENS. PROBLEM OCCURRED TWICE".

    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