BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLURA XPER FD10

    MDR report key: 1942884 · Received December 17, 2010

    Report

    Report Number
    3003768277-2010-00373
    Event Type
    Malfunction
    Date Received
    December 17, 2010
    Date of Event
    November 26, 2010
    Report Date
    November 26, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    IZI
    PMA / PMN Number
    K031333
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (CONCLUSIONS) - THE CUSTOMER REPORTED THAT THEY HEARD A LOUD NOISE AND COULD SMELL SMOKE. THE FIELD SERVICE ENGINEER INVESTIGATED AND FOUND THAT THE HIGH VOLTAGE TANK WAS DEFECTIVE. A DEFECTIVE HIGH VOLTAGE TANK PREVENTS THE SYSTEM GENERATOR FROM GENERATING SUFFICIENT ENERGY RENDERING THE X-RAY GENERATION INOPERABLE. FROM TRENDING OF SPARE PARTS USE, IT IS FOUND THAT THE REPLACEMENT RATE FOR THIS PART IS VERY LOW AND STABLE. THERE IS NO NEED FOR A MANDATORY FIELD ACTION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY HEARD A LOUD NOISE AND COULD SMELL SMOKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALLURA XPER FD10 IZI (SYSTEM, X-RAY ANGIOGRAPHIC) IZI PHILIPS MEDICAL SYSTEMS 722001 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA