BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLURA XPER FD10

    MDR report key: 1912495 · Received November 18, 2010

    Report

    Report Number
    3003768277-2010-00314
    Event Type
    Malfunction
    Date Received
    November 18, 2010
    Date of Event
    October 22, 2010
    Report Date
    October 22, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    IZI
    PMA / PMN Number
    K031333
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (CONCLUSIONS) - THE CUSTOMER REPORTED SYSTEM MALFUNCTION WHERE SYSTEM STOPPED WITHOUT AN ERROR MESSAGE DURING AN EXAM AND COULD NOT BE POWERED UP AGAIN. FSE DISPATCHED ON SITE. PROBLEM SOLVED BY REPLACING A FUSE ON POWER CIRCUIT BOARD. EXACT ROOT CAUSE UNK. REPLACEMENT OF THE FUSE ON THE POWER BOARD WHICH MIGHT HAVE CONTRIBUTED OR CAUSED THE REPORTED PROBLEM AND WHICH THEREFORE ARE SUSPECT HAS SOLVED THE PROBLEM. NONE OF THE COMPONENTS HAVE EXCEPTIONAL OR INCREASED FAILURE RATES. IT CANNOT BE PREVENTED THAT SYSTEM COMPONENTS BECOME DEFECTIVE. FAILURE RATES AND RELIABILITY OF COMPONENTS ARE MONITORED. THEREFORE, RISK TO PT REMAINS ACCEPTABLE. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE SYSTEM STOPPED WITHOUT AN ERROR MESSAGE DURING AN EXAM AND COULD NOT BE POWERED UP AGAIN. IF THIS HAPPENED DURING A CRITICAL MOMENT IN A PROCEDURE IT MIGHT LEAD TO A SERIOUS INJURY FOR THE PT IF IT WERE TO RECUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALLURA XPER FD10 IZI (SYSTEM, X-RAY ANGIOGRAPHIC) IZI PHILIPS MEDICAL SYSTEMS 722003 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA