BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AZURION

    MDR report key: 22103299 · Received May 29, 2025

    Report

    Report Number
    3003768277-2025-004870
    Event Type
    Malfunction
    Date Received
    May 29, 2025
    Date of Event
    October 21, 2021
    Report Date
    May 29, 2025
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    OWB
    UDI-DI
    00884838085251
    PMA / PMN Number
    K172822
    Removal / Correction Number
    C&R#: 3003768277-06/23/2
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT WAS SUBMITTED IN AGREEMENT WITH FDA FOR THE RETROSPECTIVE REPORTING COMMITMENT (REFERENCE: GEN2400312) AND IS RELATED TO AND OCCURRED PRIOR TO (C&R#: 3003768277-06/23/2023-004-C).

    Description of Event or Problem · 0

    IT WAS REPORTED TO PHILIPS THAT WIRELESS PEDAL NOT HOLDING CHARGE. THIS IS CONNECTED TO LOSS OF IMAGE RELATED TO A AZURION 7 M12. THERE WAS NO REPORTED PATIENT OR USER HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    746192 AZURION INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. AZURION 7 M12 00884838085251

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown