BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLURA XPER FD

    MDR report key: 19712220 · Received July 10, 2024

    Report

    Report Number
    3003768277-2024-03766
    Event Type
    Injury
    Date Received
    July 10, 2024
    Date of Event
    June 14, 2024
    Report Date
    June 17, 2025
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    OWB
    UDI-DI
    00884838054202
    PMA / PMN Number
    K162859
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PHILIPS HAS INVESTIGATED THIS COMPLAINT. A PHILIPS FIELD SERVICE ENGINEER (FSE) INSPECTED THE SYSTEM ON-SITE AND CONFIRMED THAT THE SYSTEM DID NOT EMIT X-RAYS. VISUAL INSPECTION OF THE SYSTEM ALONG WITH LOG FILE REVIEW SHOWED THE A LED STATUS INDICATOR OF THE FLAT DETECTOR CONTROLLER (FDC) WAS RED AND COMMUNICATION ERRORS BETWEEN THE FDC AND THE FLAT DETECTOR (FD) WERE NOTED. THE FSE CONFIRMED THAT BOTH THE FDC AND FD WERE RECEIVING POWER BY MEASURING THE 24-VOLT POWER SUPPLY; HOWEVER, THE FD SOFTWARE WAS NOT DETECTED BY THE SYSTEM. THE FSE RELOADED THE FD SOFTWARE, RESEATED THE OPTICAL FIBER CABLE ON THE FD SIDE, AND REBOOTED THE SYSTEM. AFTER THESE SERVICE ACTIONS, THE SYSTEM PASSED FUNCTIONAL TESTING AND WAS RETURNED TO USE IN GOOD WORKING ORDER. THE FSE RETURNED TO THE SITE AT A LATER DATE AND PERFORMED A LOOPBACK TEST ON THE OPTICAL CABLE TO CONFIRM THE CABLE REMAINED SEATED CORRECTLY. THE SYSTEM PASSED THE LOOPBACK TEST AND THERE HAS BEEN NO RECURRENCE OF THE ISSUE TO DATE. THE CODES HAVE BEEN UPDATED BASED ON THE INVESTIGATION¿S OUTCOME.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED TO PHILIPS THAT DURING AN INTERVENTIONAL TREATMENT FOR A RUPTURED CEREBRAL ANEURYSM, THE ALLURA SYSTEM WOULD NOT EMIT RADIATION, AND A SYSTEM RESTART DID NOT RESOLVE THE ISSUE. THE PROCEDURE WAS COMPLETED VIA A CRANIOTOMY AND THE PATIENT IS STABLE AND RECOVERING WELL. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2144496 ALLURA XPER FD INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. ALLURA XPER FD20 00884838054202

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other