BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLURA XPER FD

    MDR report key: 22121815 · Received June 2, 2025

    Report

    Report Number
    3003768277-2025-004938
    Event Type
    Malfunction
    Date Received
    June 2, 2025
    Date of Event
    May 19, 2025
    Report Date
    September 18, 2025
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    IZI
    PMA / PMN Number
    K130842
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PHILIPS HAS INVESTIGATED THIS COMPLAINT. ACCORDING TO ADDITIONAL INFORMATION COLLECTED, PROCEDURE WAS ABLE TO CONTINUE AFTER TWO MINUTES AS THE IMAGES BECAME AVAILABLE. A PHILIPS FIELD SERVICE ENGINEER (FSE) INSPECTED THE SYSTEM ONSITE AND FOUND IMAGE COULD NOT BE REPLAYED. ANALYSIS OF THE LOG FILES REVEALED DATA LOSS ON THE IMAGE NETWORK IPPC(IMGAE PROCESSING PC)-HOST AND IPPC POST FAILED, INDICATING AN IPPC MALFUNCTION. THE FAULTY IPPC WAS REPLACED, AND THE IPPC OPERATING SYSTEM AND APPLICATION SOFTWARE WERE REINSTALLED. THE DEFECTIVE IPPC WAS RETURNED TO PHILIPS FOR FURTHER ANALYSIS, WHICH IDENTIFIED A FAILURE AT LIN-SDK-CHK ATTRIBUTABLE TO CHASSIS INTRUSION BEING ACTIVATED. FOLLOWING THE REPLACEMENT, THE SYSTEM WAS RESTORED TO PROPER 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 BEEN RECEIVED WHICH HAS LED TO THE DETERMINATION THAT THIS IS SCENARIO IS NOT LIKELY TO CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY IF IT WERE TO RECUR. A SCENARIO WHERE THE IMAGING FUNCTIONALITY IS STILL AVAILABLE AND THE PROCEDURE CAN BE COMPLETED ON THE SAME SYSTEM, IS NOT LIKELY TO CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY SHOULD IT RECUR. THEREFORE, BASED ON THIS INVESTIGATION RESULTS, PHILIPS CONCLUDES THAT THIS COMPLAINT IS NOT REPORTABLE. BASED ON THE INVESTIGATION RESULTS, PHILIPS CONCLUDED 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 COULD NOT EMIT X-RAY AND FLUOROSCOPY STORAGE WAS NOT POSSIBLE. 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
    737125 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