BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AZURION

    MDR report key: 21897483 · Received April 24, 2025

    Report

    Report Number
    3003768277-2025-003795
    Event Type
    Malfunction
    Date Received
    April 24, 2025
    Date of Event
    April 2, 2025
    Report Date
    May 1, 2025
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    OWB
    UDI-DI
    00884838085268
    PMA / PMN Number
    K163715
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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: 3003768277-2025-003392). 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 COULD NOT EMIT X-RAY. THE DEVICE WAS IN CLINICAL USE AT THE TIME OF REPORTED 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
    706436 AZURION INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. AZURION 7 M20 00884838085268

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown