BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLURA XPER FD10

    MDR report key: 20382909 · Received October 7, 2024

    Report

    Report Number
    3003768277-2024-05718
    Event Type
    Malfunction
    Date Received
    October 7, 2024
    Date of Event
    September 17, 2024
    Report Date
    February 20, 2025
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    IZI
    PMA / PMN Number
    K041949
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PHILIPS HAS INVESTIGATED THIS COMPLAINT. ACCORDING TO THE ADDITIONAL INFORMATION COLLECTED, THE CARDIOVASCULAR DIAGNOSTIC PROCEDURE WAS PERFORMED WHEN THE ISSUE HAPPENED, AND PROCEDURE COMPLETED BY MOVING THE PATIENT TO ANOTHER ROOM. THE PHILIPS FIELD SERVICE ENGINEER (FSE) INSPECTED THE SYSTEM ONSITE AND CONFIRMED SYSTEM WAS NOT PRODUCING X-RAYS. AFTER REVIEWING LOG FILE, FSE FOUND MALFUNCTION WITH THE FDC BOARD. UPON TROUBLESHOOTING FSE FOUND FLAT DETECTOR CONTROL (FDC) BOARD WAS NOT COMMUNICATING WITH THE REST OF THE SYSTEM. TO RESOLVE THE ISSUE, THE FSE REPLACED BOTH THE FLAT DETECTOR AND THE FLAT DETECTOR CONTROL BOARD. AFTER REPLACING FLAT DETECTOR AND FLAT DETECTOR CONTROL BOARD, SYSTEM RETURNED TO GOOD WORKING CONDITION. THE CODES WERE UPDATED BASED ON THE INVESTIGATION OUTCOME.

    Description of Event or Problem · 0

    IT WAS REPORTED TO PHILIPS THAT THE SYSTEM FAILED TO PRODUCE X-RAYS. THE DEVICE WAS IN CLINICAL USE AT THE TIME OF THE REPORTED EVENT. NO HARM WAS REPORTED TO PHILIPS.PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2538927 ALLURA XPER FD10 SYSTEM, X-RAY, ANGIOGRAPHIC IZI PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. ALLURA XPER FD10

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown