BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AZURION

    MDR report key: 23220697 · Received October 6, 2025

    Report

    Report Number
    3003768277-2025-011260
    Event Type
    Injury
    Date Received
    October 6, 2025
    Date of Event
    September 5, 2025
    Report Date
    March 25, 2026
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    OWB
    PMA / PMN Number
    K200917
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PHILIPS HAS INVESTIGATED THIS COMPLAINT. ACCORDING TO THE INFORMATION COLLECTED, THERE WAS NO PATIENT OR USER HARM. THE PATIENT EXPERIENCED DISCOMFORT WHICH WAS RESOLVED BY THE PHYSICIAN ADDING A PAD TO THE ARM SUPPORT. 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, NEW INFORMATION HAS BEEN RECEIVED WHICH HAS LED TO THE DETERMINATION THAT THIS IS SCENARIO IS NOT LIKELY TO CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY IF IT WERE TO RECUR. BASED ON THE INVESTIGATION RESULTS, PHILIPS CONCLUDES THAT THE COMPLAINT IS NOT REPORTABLE. THE CODES WERE UPDATED BASED ON THE INVESTIGATION OUTCOME. THE REPORTER FIRST NAME, REPORTER LAST NAME AND THE REPORTER SALUTATION HAVE BEEN UPDATED.

    Additional Manufacturer Narrative · 0

    PHILIPS HAS INVESTIGATED THIS COMPLAINT. ACCORDING TO THE INFORMATION COLLECTED, THERE WAS NO PATIENT OR USER HARM. THE PATIENT EXPERIENCED DISCOMFORT WHICH WAS RESOLVED BY THE PHYSICIAN ADDING A PAD TO THE ARM SUPPORT. 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, NEW INFORMATION HAS BEEN RECEIVED WHICH HAS LED TO THE DETERMINATION THAT THIS IS SCENARIO IS NOT LIKELY TO CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY IF IT WERE TO RECUR. BASED ON THE INVESTIGATION RESULTS, PHILIPS CONCLUDES THAT THE COMPLAINT IS NOT REPORTABLE. THE CODES WERE UPDATED BASED ON THE INVESTIGATION OUTCOME.

    Description of Event or Problem · 0

    IT WAS REPORTED TO PHILIPS THAT DURING A CORONARY ANGIOGRAPHY, USING A HAND SUPPORT TO SUPPORT THE PATIENT'S ARM, THE PATIENT EXPERIENCED DISCOMFORT. IT WAS ALLEGED THAT DUE TO THE LENGTH OF THE SURGERY, THE HEIGHT AND ANGLE OF THE HAND SUPPORT, THE PATIENT'S DISCOMFORT WAS EXACERBATED BY PROLONGED PLACEMENT, CAUSING INCONVENIENCE TO THE OPERATOR AND AFFECTING THE ACCURACY OF THE OPERATION. NO FURTHER DETAILS REGARDING THE ALLEGED ISSUE HAVE BEEN PROVIDED TO DATE. AN INVESTIGATION INTO THIS COMPLAINT HAS BEEN INITIATED BY PHILIPS. THE COMPLAINT DEVICE 722282 - AZURION 7 M20 IS NOT SOLD IN THE US. HOWEVER, ITS SIMILAR DEVICE 722224 - AZURION 7 M20 IS MARKETED IN THE US UNDER 510(K): K200917.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1869132 AZURION INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. AZURION 7 M20

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other