BEUDAMED
    FDA Adverse Event Death Summary report: N

    ALLURA XPER FD

    MDR report key: 19417055 · Received May 29, 2024

    Report

    Report Number
    3003768277-2024-03040
    Event Type
    Death
    Date Received
    May 29, 2024
    Date of Event
    May 4, 2024
    Report Date
    December 18, 2025
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    IZI
    PMA / PMN Number
    K130842
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PHILIPS INVESTIGATED THE REPORTED ISSUE. THE PHYSICIAN USED A DIGITAL CARDIO PROTOCOL WITH SETTINGS DESIGNED TO MINIMIZE RADIATION DOSE (FLUORO MODE 1 (OUT OF 3)). WHEN TESTING THE SYSTEM, THE PHILIPS FIELD SERVICE ENGINEER (FSE) FOUND THAT, WHILE THE GENERATOR AND IMAGING SYSTEM WERE FUNCTIONING WITHOUT ERRORS, THE FLUOROSCOPY DOSE WAS CAPPED AT 5 R/MIN (THE LEGAL LIMIT IS 10 R/MIN), AND THAT THE SYSTEM¿S X-RAY OUTPUT WAS ABOUT 50% LOWER THAN EXPECTED (730 MGY/S INSTEAD OF 1395 MGY/S). CALIBRATION VALUES FOR THE X-RAY TUBE DID NOT MATCH ACTUAL MEASUREMENTS, CONFIRMING THAT THE SYSTEM WAS DELIVERING LESS X-RAY OUTPUT THAN INTENDED. THIS ISSUE WAS TRACED TO PREVENTIVE MAINTENANCE PERFORMED BY CUSTOMER¿S BIOMED STAFF IN MARCH 2024, DURING WHICH THEY INDICATED THEY HAD USED A NON-VALIDATED CALIBRATION METHOD INSTEAD OF PHILIPS¿ RECOMMENDED PROCEDURE IN THIS REGARD (PHILIPS PROVIDES ACCESS TO TOOLING TO ASSEMBLE, INSTALL, ADJUST, AND TEST (AIAT) CERTIFIED COMPONENTS TO ENSURE COMPLIANCE WITH PERFORMANCE SPECIFICATIONS AS PART OF CUSTOMER SERVICE INTELLECTUAL PROPERTY (CSIP) LEVEL 0). THIS RESULTED IN THE SYSTEM DELIVERING APPROXIMATELY HALF THE EXPECTED X-RAY DOSE. EVENT LOG DATA ANALYSIS ALSO CONFIRMED THAT THE TUBE OUTPUT WAS SIGNIFICANTLY LOWER THAN THEORETICAL VALUES. THE FSE PERFORMED TUBE ADAPTATION AND RECALIBRATED TUBE YIELD, EXPOSURE DOSE LIMIT (EDL), AND THE DETECTOR. AFTER THESE ADJUSTMENTS, THE SYSTEM PASSED ALL TESTS AND WAS RESTORED TO NORMAL DOSE OUTPUT AND IMAGE QUALITY. PHILIPS BELIEVES THAT THE IMAGE QUALITY ISSUE WAS CAUSED BY THE SELECTED FLUORO MODE (WHEREBY A FLUORO MODE WITH HIGHER POWER COULD HAVE PROVIDED A BETTER VISUAL) AND IMPROPER CALIBRATION, RESULTING IN UNDER-DELIVERY OF X-RAY DOSE WITHIN THE DIFFERENT FLUORO MODES. THE PHILIPS SYSTEM WAS NOT DEFECTIVE AND PERFORMED IN ACCORDANCE WITH ITS SPECIFICATIONS. AFTER RECALIBRATION, THE SYSTEM MET ALL PERFORMANCE SPECIFICATIONS AND WAS RETURNED TO FULL OPERATIONAL STATUS.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED TO PHILIPS THAT THERE WERE IMAGE QUALITY ISSUES EXPERIENCED DURING A CORONARY PROCEDURE. THE PATIENT WAS NOTED TO BE CRITICALLY ILL WITH A 95% OCCLUSION OF CORONARY VESSELS. THE PHYSICIAN REPORTED BEING UNABLE TO VISUALIZE THE STENT AND MADE THE DECISION TO TRANSFER THE PATIENT TO A DIFFERENT INTERVENTIONAL SUITE TO COMPLETE THE PROCEDURE. THE PATIENT PASSED AWAY DURING TRANSFER TO AN ALTERNATE ROOM. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1939424 ALLURA XPER FD SYSTEM, X-RAY, ANGIOGRAPHIC IZI PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. ALLURA XPER FD10

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Death