BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLURA XPER FD

    MDR report key: 23598163 · Received November 19, 2025

    Report

    Report Number
    3003768277-2025-014966
    Event Type
    Malfunction
    Date Received
    November 19, 2025
    Date of Event
    October 30, 2025
    Report Date
    January 16, 2026
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    IZI
    PMA / PMN Number
    K130842
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PHILIPS HAS INVESTIGATED THIS COMPLAINT. ACCORDING TO THE ADDITIONAL INFORMATION COLLECTED, THE ISSUE OCCURRED DURING PERFORMING CORONARY PLANNED TREATMENT. THE PROCEDURE WAS DELAYED FOR ONE HOUR AND IT WAS COMPLETED BY USING ANOTHER SYSTEM. THE PHILIPS REMOTE SERVICE ENGINEER (RSE) ANALYZED THE SYSTEM REMOTELY AND CONFIRMED THAT THE SYSTEM WAS UNABLE TO PERFORM FLUOROSCOPY. REVIEW OF THE LOGFILE SHOWS FD-CONTROLLER: IOBOARD UART PARITY ERROR CONFIRMING THE MALFUNCTION. UPON TROUBLESHOOTING, THE PHILIPS FIELD SERVICE ENGINEER (FSE) CHECKED THE SYSTEM ONSITE AND FOUND THAT THE VOLTAGE WAS UNSTABLE AND IT HAD DROPPED IN THE UNIT THAT SUPPLIES POWER TO THE FPD (DETECTOR). FSE CONFIRMED THE RELAY FOR THE FPD POWER SUPPLY IN THE M CABINET WAS NOT OPERATING. TO RESOLVE THE ISSUE FSE REPLACED THE POWER SUPPLY FLAT DETECTOR (PS FD) UNIT. THE DEFECTIVE PART WAS SENT FOR ANALYSIS, FOR FD CONTROLLER FAILURE WAS OBSERVED AND THE FAILED COMPONENT WAS FOUND TO BE FAULTY CAPACITORS. AFTER REPLACEMENT, THE SYSTEM RETURNED TO USE IN GOOD WORKING ORDER. THE CODES WERE UPDATED BASED ON THE INVESTIGATION OUTCOME.

    Description of Event or Problem · 0

    IT WAS REPORTED TO PHILIPS THAT THE SYSTEM WAS UNABLE TO PERFORM FLUOROSCOPY.THE DEVICE WAS IN CLINICAL USE AT THE TIME OF 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
    2310247 ALLURA XPER FD SYSTEM, X-RAY, ANGIOGRAPHIC IZI PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. ALLURA XPER FD20

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown