BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRIS ALLURA 15 12 (MONO)

    MDR report key: 1912485 · Received November 17, 2010

    Report

    Report Number
    3003768277-2010-00316
    Event Type
    Malfunction
    Date Received
    November 17, 2010
    Date of Event
    October 21, 2010
    Report Date
    October 21, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    IZI
    PMA / PMN Number
    K002016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (CONCLUSIONS) - THE CUSTOMER REPORTED FLUORO SCREEN WHITING OUT DURING PROCEDURE. FSE WAS DISPATCHED AND FOUND THAT THE PHOTODIODE IN CONTROL FEEDBACK LOOP, REGULATING THE RADIATION EMISSION WAS NOT WORKING ACCORDING TO SPECIFICATION. THIS RESULTED IN THE SYSTEM DRIVING TO MAXIMUM ALLOWED KV EMITTING MORE RADIATION THAN NEEDED, WHILE NOT RESULTING IN A USEABLE IMAGE. PROBLEM IS CLEARLY VISIBLE TO USER. IT CANNOT BE PREVENTED THAT PARTS BECOME DEFECTIVE. FROM INVESTIGATION IT IS CONCLUDED THAT THE BY FSE CALIBRATED PART WAS A HIGH RELIABILITY AND LOW, STABLE REPLACEMENT RATE. THEREFORE, THE RISK ESTIMATION THAT THE HAZARD POSSIBLY MIGHT POSE TO PT HEALTH REMAINS ACCEPTABLE. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED FLUORO SCREEN WHITING OUT DURING PROCEDURE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA