BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRIS ALLURA 15-12

    MDR report key: 1942727 · Received November 29, 2010

    Report

    Report Number
    3003768277-2010-00335
    Event Type
    Malfunction
    Date Received
    November 29, 2010
    Date of Event
    November 3, 2010
    Report Date
    November 3, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    IZI
    PMA / PMN Number
    K002016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (CONCLUSIONS) - THE INVESTIGATION FOUND THAT THERE WAS A DEFECTIVE X-RAY TUBE. IT WAS REPLACED AND RESOLVED THE PROBLEM. ALSO, REVIEWING THE TRENDING FAILURE ANALYSIS IT WAS CONCLUDED THERE IS NO EXCEPTIONAL TUBE REPLACEMENT RATE. THEREFORE, THERE IS NO NEED FOR A MANDATORY FIELD ACTION. (B)(4).

    Description of Event or Problem · 1

    THIS X-RAY SYSTEM'S FLUORO IMAGE WAS VERY FAINT WITH AN UNREADABLE DARKEN IMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTEGRIS ALLURA 15-12 IZI (SYSTEM, X-RAY ANGIOGRAPHIC) IZI PHILIPS MEDICAL SYSTEMS 722043 NA

    Patients

    Seq Age Sex Outcome Treatment
    1