MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. AZURION; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Model Number	AZURION 7 M12
Medical Device Problem Code	Radiation Output Failure (4027)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to philips that the system displayed a collimator error, which could impact imaging.No harm to the patient or user was reported.Philips has started an investigation of this complaint.
Additional Manufacturer Narrative
Philips has investigated this complaint.According to the additional information collected, the issue occurred during the planned treatment.The procedure was completed after restarting the system, with a delay of less than 20 minutes.The philips field service engineer (fse) inspected the system onsite and confirmed that there was an intermittent blockage of the collimator due to the filter being in the beam.Upon troubleshooting actions, the fse identified that a collimator driver detector related to the shutters and the collimator driver aep were unavailable.The defective collimator was returned for analysis, which concluded that the wedge, shutter x encoder count was faulty.To resolve the issue, the fse replaced the collimator.After replacement, the system was returned to use in good working order.At the time this complaint was received, philips did not have enough information to exclude a product malfunction with 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.A scenario where the procedure can be completed on the same system by restarting with minimal delay, is not likely to cause or contribute to death or serious injury should it recur.Therefore, based on this investigation results, philips concludes that this complaint is not reportable.The codes were updated based on the investigation outcome.

• Brand Name: AZURION
• Common Device Name: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; veenpluis 6; best 5684 PC; NL 5684 PC
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; veenpluis 6; best 5684 PC; NL 5684 PC
• Manufacturer Contact: marjan vos ; veenpluis 6; best 5684 -PC ; NL 5684 PC
• MDR Report Key: 22409453
• Report Number: 3003768277-2025-006086
• Device Sequence Number: 8353313
• Product Code: OWB
• UDI-Device Identifier: 00884838116764
• UDI-Public: (01)00884838116764
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K200917
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: AZURION 7 M12
• Device Catalogue Number: 722233
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2025
• Supplement Date Received by Manufacturer: 09/15/2025
• Initial Report FDA Received Date: 07/07/2025
• Supplement Report FDA Received Date: 09/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/28/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown