BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLURA XPER FD20

    MDR report key: 21793466 · Received April 7, 2025

    Report

    Report Number
    3003768277-2025-003202
    Event Type
    Malfunction
    Date Received
    April 7, 2025
    Date of Event
    March 10, 2025
    Report Date
    May 14, 2025
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    OWB
    PMA / PMN Number
    K033737
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PHILIPS HAS INVESTIGATED THIS COMPLAINT. ACCORDING TO ADDITIONAL INFORMATION COLLECTED, THE SYSTEM WAS NOT IN CLINICAL USE WHEN THE ISSUE WAS IDENTIFIED. THE PHILIPS FIELD SERVICE ENGINEER (FSE) CHECKED THE SYSTEM ONSITE AND CONFIRMED THAT THE SYSTEM UNABLE TO BOOT. UPON TROUBLESHOOTING, PHILIPS FIELD SERVICE ENGINEER (FSE) CHECKED THE SYSTEM ONSITE AND FOUND THAT POWER SUPPLY IN C ARM WENT OUT AND LUC BOARD. TO RESOLVE THE ISSUE, THE FSE REALIGNED THE POWER SUPPLY IN LUC BOARD AND DID SOME READJUSTMENTS. AFTER REPAIRS THE DEVICE RETURNED TO GOOD WORKING ORDER. THE CODES WERE UPDATED BASED ON THE INVESTIGATION OUTCOME.

    Description of Event or Problem · 0

    IT WAS REPORTED TO PHILIPS THAT SYSTEM'S GEOMETRY COMPUTER WAS UNABLE TO BOOT UP, PREVENTING A FULL SYSTEM BOOT. THE DEVICE WAS IN CLINICAL USE AT THE TIME OF THE EVENT. NO HARM TO THE PATIENT OR USER WAS REPORTED. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    646750 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