BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLURA XPER FD20

    MDR report key: 22295988 · Received June 20, 2025

    Report

    Report Number
    3003768277-2025-005698
    Event Type
    Malfunction
    Date Received
    June 20, 2025
    Date of Event
    June 15, 2025
    Report Date
    August 29, 2025
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    OWB
    PMA / PMN Number
    K033737
    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. A PHILIPS FIELD SERVICE ENGINEER (FSE) INSPECTED THE SYSTEM ON-SITE AND CONFIRMED THE REPORTED ISSUE. TROUBLESHOOTING DETERMINED THAT THE SINGLE BOARD COMPUTER (SBC) FAILED TO BOOT AND THE FSE SUSPECTED THAT THE PC BOX OR THE SBC WERE DEFECTIVE. THE FSE REPLACED BOTH THE PC BOX AND THE SBC. AFTER THE PC BOX AND SBC WERE REPLACED, THE SYSTEM WAS FUNCTIONING AS INTENDED AND WAS RETURNED TO USE IN GOOD WORKING ORDER THE CODES WERE UPDATED BASED ON THE INVESTIGATION OUTCOME.

    Description of Event or Problem · 0

    IT WAS REPORTED TO PHILIPS THAT THE SYSTEM COULD NOT START UP. THE DEVICE WAS OUTSIDE OF CLINICAL USE AT THE TIME OF THE 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
    1723597 ALLURA XPER FD20 INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. ALLURA XPER FD20

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown