BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLURA XPER FD10

    MDR report key: 20975854 · Received December 19, 2024

    Report

    Report Number
    3003768277-2024-007398
    Event Type
    Malfunction
    Date Received
    December 19, 2024
    Date of Event
    December 12, 2024
    Report Date
    April 24, 2025
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    IZI
    PMA / PMN Number
    K041949
    Removal / Correction Number
    Z-1156-2024
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PHILIPS HAS INVESTIGATED THIS COMPLAINT. THE PHILIPS FIELD SERVICE ENGINEER (FSE) VISITED THE SYSTEM ONSITE AND FOUND THAT THERE WAS A MEMORY PROBLEM WITH THE HOST PC. ANALYSIS OF THE LOG FILE SHOWED A MEMORY PROBLEM IN THE HOST PC. UPON TROUBLESHOOTING, THE FSE FOUND INTERMITTENT PROBLEMS IN THE HOST PC. TO RESOLVE THE ISSUE, THE FSE REPLACED THE HOST PC, HARD DISK AND RELOADED THE SOFTWARE. THE DEFECTIVE HOST PC WAS RETURNED TO PHILIPS FOR FAILURE ANALYSIS, AND THE FAILURE ANALYSIS SHOWED FAILED COMPONENTS RAM. THE DESCRIPTION OF THE TEST PERFORMED WAS "INCORRECT RAM SIZE. DUE TO MANUFACTURING ISSUES, 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-1156-2024. AFTER THE REPLACEMENT OF THE HOST PC, THE SYSTEM WAS 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 THERE WAS A MEMORY PROBLEM WITH THE HOST PC. THE DEVICE WAS OUTSIDE OF CLINICAL USE AT THE TIME OF THE REPORTED EVENT. NO HARM WAS REPORTED TO PHILIPS. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLIANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1988502 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