BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLURA XPER FD10

    MDR report key: 19199426 · Received April 29, 2024

    Report

    Report Number
    3003768277-2024-02459
    Event Type
    Malfunction
    Date Received
    April 29, 2024
    Date of Event
    April 19, 2024
    Report Date
    January 17, 2025
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    IZI
    PMA / PMN Number
    K041949
    Removal / Correction Number
    3003768277-12/28/2023-01
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PHILIPS HAS INVESTIGATED THIS COMPLAINT. ACCORDING TO THE ADDITIONAL INFORMATION COLLECTED, THE SYSTEM WAS NOT IN CLINICAL USE WHEN THE ISSUE WAS IDENTIFIED. THE PHILIPS FIELD SERVICE ENGINEER (FSE) INSPECTED THE DEVICE ONSITE AND CONFIRMED THAT THE SYSTEM WAS UNABLE TO STORE IMAGES. REVIEW OF THE LOG FILE CONFIRMED THE REPORTED MALFUNCTION WITH THE IMAGE PROCESSING PC (IP PC). THE CAUSE OF THE IP PC FAILURE WAS DETERMINED TO BE A HARD DISK DRIVE ISSUE BY THE SUPPLIER'S PART ANALYSIS. TO SOLVE THE ISSUE, FSE REPLACED THE IP PC, HARD DISKS AND LOADED SOFTWARE. AFTER THE REPLACEMENT, THE SYSTEM WAS RETURNED TO USE IN 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, IT WAS IDENTIFIED THAT THE ISSUE OCCURRED WITHOUT PATIENT INVOLVEMENT AND WAS IDENTIFIABLE PRIOR TO PROCEDURE COMMENCEMENT, 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. AS PER THE INSTRUCTIONS FOR USE, THE USER OF THE PRODUCT MUST INSTITUTE A USER ROUTINE CHECKS PROGRAM. THE USER OF THE PRODUCT SHALL MAKE SURE THAT ALL CHECKS AND ACTIONS HAVE BEEN SATISFACTORILY COMPLETED BEFORE USING THE PRODUCT FOR ITS INTENDED PURPOSE. IT IS INSTRUCTED TO NOT USE THE PRODUCT FOR ANY APPLICATION UNTIL THE USER IS SURE THAT THE USER ROUTINE CHECKS HAVE BEEN SATISFACTORILY COMPLETED, THEREFORE, AS THE DEVICE WAS OUTSIDE OF USE AT THE TIME THE ISSUE WAS IDENTIFIED, THE USER WOULD IDENTIFY THIS ISSUE PRIOR TO USE. BASED ON RE-EVALUATION, THIS CASE IS NOT REPORTABLE. THE CODES WERE UPDATED BASED ON THE INVESTIGATION OUTCOME.

    Additional Manufacturer Narrative · 0

    THIS REPORT WAS SUBMITTED TO PROVIDE THE LINKAGE TO AN EXISTING CORRECTION & REMOVAL (3003768277-12/28/2023-010-C). THE REPORTED EVENT OCCURRED PRIOR TO COMPLETION OF THE FIELD CORRECTION 3003768277-12/28/2023-010-C, WHICH ADDRESSES THE CAUSES ASSOCIATED WITH THE REPORTED MALFUNCTION.

    Description of Event or Problem · 0

    IT WAS REPORTED TO PHILIPS THAT DUE TO LOW STORAGE ISSUE FLUOROSCOPY WAS NOT POSSIBLE. 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
    980984 ALLURA XPER FD10 SYSTEM, X-RAY, ANGIOGRAPHIC. IZI PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. ALLURA XPER FD10

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown