BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLURA XPER FD

    MDR report key: 21838117 · Received April 15, 2025

    Report

    Report Number
    3003768277-2025-003455
    Event Type
    Malfunction
    Date Received
    April 15, 2025
    Date of Event
    April 1, 2025
    Report Date
    July 9, 2025
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    OWB
    PMA / PMN Number
    K162859
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PHILIPS HAS INVESTIGATED THIS COMPLAINT. ACCORDING TO THE ADDITIONAL INFORMATION COLLECTED, CORONARY PROCEDURE WAS COMPLETED BY RESTARTING THE SYSTEM. THE PHILIPS FEILD SERVICE ENGINEER WENT ONSITE AND ANALYSED THE SYSTEM LOG FILE AND FOUND GEOMETRY INPUT OUTPUT BOX PORT 3 ERROR AND FAULT IN GIB. THE CAUSE OF THE GIB FAILURE COULD NOT BE CONCLUSIVELY DETERMINED BY THE SUPPLIER'S PART ANALYSIS, HOWEVER THE REPLACEMENT OF THE GIB BY THE FIELD SERVICE ENGINEER HAS RESOLVED THE REPORTED ISSUE AND RESTORED THE FUNCTIONALITY OF THE SYSTEM. AFTER REPLACEMENT, THE SYSTEM WAS 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 AN 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. AN 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 HAVE BEEN UPDATED BASED ON THE INVESTIGATION'S OUTCOME.

    Description of Event or Problem · 0

    IT WAS REPORTED TO PHILIPS THAT THE SYSTEM GEOMETRY MOVEMENT FAILED. THE DEVICE WAS IN CLINICAL USE AT THE TIME OF THE EVENT. NO HARM TO THE PATIENT OR USER WAS REPORTED. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110080 ALLURA XPER FD INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. ALLURA XPER FD20

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown