BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLURA XPER FD

    MDR report key: 18676702 · Received February 9, 2024

    Report

    Report Number
    3003768277-2024-00786
    Event Type
    Malfunction
    Date Received
    February 9, 2024
    Date of Event
    January 26, 2024
    Report Date
    January 15, 2025
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    IZI
    UDI-DI
    00884838059030
    PMA / PMN Number
    K041949
    Removal / Correction Number
    3003768277-12/28/2023-01
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    PHILIPS HAS INVESTIGATED THE COMPLAINT. ACCORDING TO THE ADDITIONAL INFORMATION COLLECTED, THE SYSTEM WAS IN CLINICAL USE FOR A CORONARY DIAGNOSIS PROCEDURE. THE PROCEDURE WAS COMPLETED AS PLANNED. THE SYSTEM WAS SLOW AS THE HOST PC WAS SLIGHTLY DEGRADED BUT HAD NO PATIENT IMPACT. THE PHILIPS FIELD SERVICE ENGINEER (FSE) INSPECTED THE SYSTEM ONSITE AND CONFIRMED THAT THE HOST PC MEMORY 2 HAD A PROBLEM RECEIVED VIA REMOTE ALERT. UPON TROUBLESHOOTING, FSE FOUND THE DUAL IN-LINE MEMORY MODULES (DIMMS) WITHIN THE HOST PC DID NOT START UP CORRECTLY. DUE TO MANUFACTURING ISSUES, THE DIMMS MAY NOT FUNCTION AS INTENDED, LEADING TO ISSUES WITH THE ALLURA XPER AND ALLURA CENTRON SYSTEMS IMAGING PROCESSING PC, HOST PC, AND FLEXVISION PC. IF ONE OF THESE PCS BREAKS DOWN, THE SYSTEM STOPS FUNCTIONING, AND NO IMAGING IS POSSIBLE. PHILIPS HAS INITIATED A MEDICAL DEVICE CORRECTION Z-1156-2024. TO RESOLVE THE ISSUE, FSE REPLACED HARD DISKS AND HOST PC. AFTER WHICH, THE SYSTEM WAS RETURNED TO USE IN GOOD WORKING ORDER. THE CODES WERE UPDATED BASED ON THE INVESTIGATION OUTCOME. THE EVALUATION METHOD CODE WAS CORRECTED.

    Description of Event or Problem · 0

    IT WAS REPORTED TO PHILIPS THAT HOST PC MEMORY 2 HAD A PROBLEM. 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
    1283646 ALLURA XPER FD SYSTEM, X-RAY, ANGIOGRAPHIC IZI PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. ALLURA XPER FD10 00884838059030

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown