BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLURA XPER FD

    MDR report key: 21863439 · Received April 18, 2025

    Report

    Report Number
    3003768277-2025-003566
    Event Type
    Malfunction
    Date Received
    April 18, 2025
    Date of Event
    April 9, 2025
    Report Date
    April 25, 2025
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    OWB
    UDI-DI
    00884838054226
    PMA / PMN Number
    K161563
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PHILIPS HAS REVIEWED THIS COMPLAINT. ACCORDING TO THE INFORMATION COLLECTED, THIS COMPLAINT IS CONFIRMED AS A DUPLICATE OF A PREVIOUSLY REPORTED EVENT (FDA REFERENCE: 3003768277-2025-003504). AT THE TIME THIS COMPLAINT WAS RECEIVED, PHILIPS DID NOT HAVE ENOUGH INFORMATION TO EXCLUDE THE POTENTIAL FOR DEATH OR SERIOUS INJURY ON RECURRENCE, AND AS SUCH THE COMPLAINT WAS REPORTED. SINCE THAT TIME, IT HAS BEEN DETERMINED THAT THE REPORTED EVENT WAS PREVIOUSLY INVESTIGATED AND REPORTED. INTERNAL EVALUATION HAS CONFIRMED THAT NO NEW ALLEGATIONS OF DEVICE MALFUNCTION OR PATIENT/USER HARM HAVE BEEN RECEIVED RELATED TO THE EVENT. THE CODES WERE UPDATED BASED ON THE INVESTIGATION OUTCOME.

    Description of Event or Problem · 0

    IT WAS REPORTED TO PHILIPS THAT THE SYSTEM FAILED DUE TO A HOST-PC MEMORY ISSUE. THE DEVICE WAS OUTSIDE CLINICAL USE AT THE TIME OF THE EVENT. NO HARM WAS REPORTED TO PHILIPS. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLIANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31126 ALLURA XPER FD INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. ALLURA XPER FD20/20 00884838054226

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown