BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLURA XPER FD

    MDR report key: 20546748 · Received October 28, 2024

    Report

    Report Number
    3003768277-2024-06146
    Event Type
    Malfunction
    Date Received
    October 28, 2024
    Date of Event
    October 7, 2024
    Report Date
    August 12, 2025
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    OWB
    UDI-DI
    00884838054196
    PMA / PMN Number
    K161563
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PHILIPS HAS INVESTIGATED THIS COMPLAINT. ACCORDING TO THE INFORMATION COLLECTED, THE SYSTEM'S CLINICAL USE AT THE EVENT WAS UNKNOWN. A PHILIPS FSE INSPECTED THE SYSTEM ON-SITE AND CONFIRMED THE BIOMED STAFF SUBMITTED THE CASE TO EXPEDITE THE DISK BAY FCO. ON 14-OCT-2024, THE ASSIGNED FCO FOR THIS SYSTEM WAS FOUND INCORRECT. THE FSE SUBMITTED A CHANGE REQUEST TO THE IGT FCO EMAIL. THE DEVICE REMAINED IN SERVICE WITH USAGE RESTRICTIONS WHILE WAITING FOR THE CORRECT FCO KIT. TO RESOLVE THE ISSUE EVENTUALLY, PHILIPS IMPLANTING THE CORRECTION ON 20-FEB-2025 ANOTHER WORK ORDER. AFTER IMPLEMENTING THE CORRECTION, THE SYSTEM WAS RETURNED TO USE IN GOOD WORKING ORDER. THE CODES WERE UPDATED BASED ON THE INVESTIGATION OUTCOME.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED TO PHILIPS THAT THE SYSTEM GAVE IMAGE DISK FULL ERRORS, PREVENTING THE SYSTEM FROM IMAGING. THE SYSTEM WAS IN CLINICAL USE AT THE TIME OF THE REPORTED EVENT. THERE WAS NO REPORTED PATIENT OR USER HARM. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1167922 ALLURA XPER FD INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. ALLURA XPER FD10/10 00884838054196

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown