BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLURA XPER FD

    MDR report key: 21089277 · Received January 7, 2025

    Report

    Report Number
    3003768277-2025-000111
    Event Type
    Malfunction
    Date Received
    January 7, 2025
    Date of Event
    December 26, 2024
    Report Date
    March 11, 2025
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    OWB
    UDI-DI
    00884838054240
    PMA / PMN Number
    K162859
    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. ACCORDING TO THE ADDITIONAL INFORMATION COLLECTED, THE ISSUE OCCURRED DURING DIAGNOSIS AND PLANNED TREATMENT/NON-EMERGENCY TREATMENT OF GENERAL SURGERY PROCEDURE. THE PROCEDURE WAS COMPLETED AS PLANNED AND RESTARTING THE SYSTEM. IT WAS REPORTED TO THAT THE GEOMETRY MOVEMENTS WERE UNAVAILABLE. UPON TROUBLESHOOTING, THE FIELD SERVICE ENGINEER (FSE) VISITED ONSITE, CHECKED THE SYSTEM AND FOUND THAT INTERMITTENT ISSUE POST GIO BOX ERRORS, GIO BOX POST FAILED. TO RESOLVE THE ISSUE, FSE REPLACED THE GIO BOX. THE DEFECTIVE PARTS WERE RETURNED FOR ANALYSIS, FOR GEO IO BOX, MALFUNCTION WAS OBSERVED, AND THE ROOT CAUSE WAS FOUND TO BE ELECTRICAL DEFECT. AFTER REPLACEMENT THE DEVICE RETURNED TO GOOD WORKING ORDER. AT THE TIME THIS COMPLAINT WAS RECEIVED, PHILIPS DID NOT HAVE ENOUGH INFORMATION TO EXCLUDE THE POTENTIAL FOR DEATH OR SERIOUS INJURY ON RECURRENCE, AND AS SUCH THE COMPLAINT WAS REPORTED. SINCE THAT TIME, NEW INFORMATION HAS IDENTIFIED THAT THE ISSUE WAS RESOLVED VIA A RESTART, WHICH ALLOWED FOR PROCEDURAL CONTINUATION. IF GEOMETRY MOVEMENT ISSUE OCCURS DURING A PROCEDURE, A WARM/FAST RESTART OR A COLD RESTART MAY BE PERFORMED IN AN ATTEMPT TO RESOLVE THE ISSUE. BY USING THESE MITIGATIONS PROVIDED BY THE DESIGN OF THE DEVICE, THE ISSUE MAY RESOLVE, ALLOWING FOR CONTINUATION AND COMPLETION OF THE PROCEDURE. A MOVEMENT ISSUE WHICH CAN BE RESOLVED BY UTILIZING THE DESIGN MITIGATIONS PROVIDED BY THE DEVICE (WARM/FAST RESTART OR COLD RESTART) IS NOT LIKELY TO CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY IF IT WERE TO RECUR AND AS SUCH PHILIPS CONCLUDES THAT THE COMPLAINT IS NOT REPORTABLE. THE CODES WERE UPDATED BASED ON THE INVESTIGATION OUTCOME.

    Description of Event or Problem · 0

    IT WAS REPORTED TO PHILIPS THAT THE GEOMETRY MOVEMENTS WERE UNAVAILABLE. THE DEVICE WAS IN CLINICAL USE AT THE TIME OF THE 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
    1010920 ALLURA XPER FD INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. ALLURA XPER FD20 OR TABLE 00884838054240

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown