BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLURA XPER FD

    MDR report key: 18275256 · Received December 6, 2023

    Report

    Report Number
    3003768277-2023-06772
    Event Type
    Malfunction
    Date Received
    December 6, 2023
    Date of Event
    November 28, 2023
    Report Date
    September 2, 2024
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    IZI
    UDI-DI
    00884838059054
    PMA / PMN Number
    K130842
    Removal / Correction Number
    Z-1151-2024, Z-1156-2024
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PHILIPS HAS INVESTIGATED THIS COMPLAINT. ACCORDING TO THE ADDITIONAL INFORMATION COLLECTED, THE SYSTEM WAS NOT IN CLINICAL USE WHEN THE ISSUE OCCURRED. THE PHILIPS FIELD SERVICE ENGINEER (FSE) INSPECTED THE SYSTEM ONSITE AND CONFIRMED THAT THE SYSTEM DID NOT BOOT UP. ANALYSIS OF THE SYSTEM LOG FILES SHOWED THE MALFUNCTIONING OF THE FRONTAL IMAGE PROCESSING PC (IPPC). UPON TROUBLESHOOTING, FSE FOUND THAT THE FLEXVISION PC AND HOST PC WERE NOT STARTING WITH THE IP-PC. FSE REPLACED THE HOST PC AND FLEXVISION PC AND RELOADED THE SOFTWARE TO BOTH PCS. FSE UPGRADED THE SYSTEM SOFTWARE TO FACILITATE THE REPLACEMENT OF THE IP-PC. FSE REPLACED IPPC AND THE HARD DISK DRIVE WAS REPLACED AS A PART OF THE UPGRADE. LATER, FSE FOUND A HARDWARE ISSUE WITH THE 58¿ COLOR LCD MONITOR AND REPLACED THE LCD MONITOR AS WELL. DUE TO MANUFACTURING ISSUES, THE DISK BAY AND THE DIMMS (DUAL IN-LINE MEMORY MODULES) MAY NOT FUNCTION AS INTENDED, LEADING TO ISSUES WITH THE ALLURA XPER AND ALLURA CENTRON SYSTEM'S IMAGING PROCESSING PC, HOST PC, AND FLEXVISION PC. IF ONE OF THESE PCS BREAKS DOWN, THE SYSTEM STOPS FUNCTIONING, AND NO IMAGING IS POSSIBLE. PHILIPS HAS INITIATED A MEDICAL DEVICE CORRECTION Z-1151-2024 FOR DISK BAY AND Z-1156-2024 FOR DIMMS. AFTER REPLACEMENT OF DEFECTIVE PARTS, THE SYSTEM WAS RETURNED TO GOOD WORKING CONDITION. THE DEFECTIVE PARTS WERE RETURNED TO PHILIPS FOR ANALYSIS. THE CAUSE OF THE FAILURE OF HOST PC WAS FOUND TO BE VIDEO GRAPHICS ARRAY (VGA) FAILED; FAILURE MODE IS VIDEO/SCREEN MALFUNCTION, AND THE CAUSE OF FAILURE OF IPPC WAS FOUND TO BE TYLERSBURG MB W/MAIN BIOS & BASEBOARD MANAGEMENT CONTROLLER (BMC) IMAGE IS FAILED. TYLERSBURG MB IS AN INTEL X58 CHIP USED TO INTERFACE PERIPHERAL DEVICES AND USED IN NEHALEM PCS.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED TO PHILIPS THAT THE SYSTEM DID NOT BOOT UP SUCCESSFULLY. NO HARM HAS BEEN REPORTED TO PHILIPS. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2044201 ALLURA XPER FD SYSTEM, X-RAY, ANGIOGRAPHIC IZI PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. ALLURA XPER FD20 00884838059054

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown