BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLURA XPER FD10

    MDR report key: 1942867 · Received December 16, 2010

    Report

    Report Number
    3003768277-2010-00376
    Event Type
    Malfunction
    Date Received
    December 16, 2010
    Date of Event
    November 18, 2010
    Report Date
    November 18, 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

    CONCLUSION: THE CUSTOMER REPORTED THAT THE SYSTEM WENT DOWN DURING A GEOPLASTIC OPERATION. A FIELD SERVICE ENGINEER WAS DISPATCHED TO THE SITE AND FOUND A DEFECTIVE FUSE, WHICH WAS REPLACED. DUE TO THE UNKNOWN CAUSE, WE CONSIDER THE FUSE TO HAVE BEEN DEFECTIVE, THEREFORE, THE PROBLEM IS CONSIDERED TO BE REPORTABLE, SINCE BASIC SYSTEM FUNCTIONALITY IS LOST. HOWEVER, FROM TRENDING ANALYSIS, IT IS FOUND THAT THE REPLACED FUSE HAS A STABLE REPLACEMENT RATE. THERE IS NO NEED FOR A MANDATORY FIELD ACTION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM WENT DOWN DURING A GEOPLASTIC OPERATION.

    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