BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLURA XPER FD

    MDR report key: 17235844 · Received June 30, 2023

    Report

    Report Number
    3003768277-2023-03867
    Event Type
    Malfunction
    Date Received
    June 30, 2023
    Date of Event
    June 22, 2023
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    OWB
    UDI-DI
    00884838059030
    PMA / PMN Number
    K130638
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED ON THE (B)(6) 2023 THAT THE FSE REPLACED THE FLEXVISION PC AND THE HARD DISKS ON THE ALLURA DEVICE. IT HAS SINCE BEEN CONFIRMED THAT ONLY THE FLEXVISION PC WAS REPLACED, AND NOT THE HARD DISKS.

    Additional Manufacturer Narrative · 0

    THE PHILIPS FIELD SERVICE ENGINEER (FSE) INSPECTED THE SYSTEM ONSITE AND CONFIRMED THAT THE SYSTEM WAS NOT STARTING. REVIEW OF THE SYSTEM LOG FILE SHOWED THAT FRAME GRABBER CARD ERROR RESULTED IN THE SYSTEM NOT BEING ABLE TO COMPLETE THE STARTUP SEQUENCE. THE FRAME GRABBER CAPTURES THE VIDEO FROM THE ALLURA SYSTEM. THE FRAME GRABBER CARD IN THE FLEXVISION PC FAILED. THE FSE REPLACED THE FLEXVISION PC AND INSTALLED THE SOFTWARE. AFTER REPLACEMENT OF THE FLEXVISION PC AND INSTALLATION OF THE SOFTWARE, THE SYSTEM WAS RETURNED TO USE IN GOOD WORKING ORDER. THE DEFECTIVE PART WAS RETURNED FOR ANALYSIS AND INVESTIGATION CONFIRMS THE ISSUE AND THE CAUSE IS UPGRADED FRAME GRABBERS PER PRQ. THE CODES WERE UPDATED BASED ON THE INVESTIGATION OUTCOME. EVALUATION METHOD CODE WAS CORRECTED.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED TO PHILIPS THAT THE ALLURA SYSTEM DID NOT BOOT UP SUCCESSFULLY, IT GOT STUCK AT 00:00. THE SYSTEM WAS NOT IN CLINICAL USE. NO HARM HAS BEEN REPORTED TO PHILIPS. A PHILIPS FIELD SERVICE ENGINEER (FSE) INSPECTED THE SYSTEM ONSITE AND CONFIRMED THAT THE SYSTEM WAS NOT STARTING. TROUBLESHOOTING ACTIONS SHOWED A PROBLEM WITH THE FLEXVISION PC. THE FSE REPLACED THE FLEXVISION PC AND REINSTALLED THE SOFTWARE WHICH RETURNED THE SYSTEM TO USE IN GOOD WORKING ORDER.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED TO PHILIPS THAT THE ALLURA SYSTEM DID NOT BOOT UP SUCCESSFULLY, IT GOT STUCK AT 00:00. THE SYSTEM WAS NOT IN CLINICAL USE. NO HARM HAS BEEN REPORTED TO PHILIPS. A PHILIPS FIELD SERVICE ENGINEER (FSE) INSPECTED THE SYSTEM ONSITE AND CONFIRMED THAT THE SYSTEM WAS NOT STARTING. TROUBLESHOOTING ACTIONS SHOWED A PROBLEM WITH THE FLEXVISION PC. THE FSE REPLACED THE FLEXVISION PC AND THE HARD DISKS, REINSTALLED THE SOFTWARE AND RETURNED THE SYSTEM TO USE IN GOOD WORKING ORDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1447547 ALLURA XPER FD INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. ALLURA XPER FD10 00884838059030

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown