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

Model Number	AZURION 3 M12
Medical Device Problem Code	Radiation Output Failure (4027)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to philips that the system was unable to perform exposure.No harm was reported to philips.Philips has started an investigation of this complaint.
Additional Manufacturer Narrative
Philips has investigated this complaint.According to the additional information collected, the coronary diagnosis procedure was performed when the issue happened.The procedure was completed as planned as issue did not affect the procedure.A philips rse reported the system is working, but the user complains about image quality.The quotation has been cancelled by the customer and service has not been provided because user has not given the system for checking.No work performed by philips.At the time this complaint was received, philips did not have enough information to exclude a potential for serious injury 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.According to the information obtained, the procedure remained unaffected, allowing the customer to successfully completed on same as planned.The procedure was finalized without a delay on the same system, 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.Evaluation method code was corrected.

• 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: 22687790
• Report Number: 3003768277-2025-007058
• Device Sequence Number: 15844258
• Product Code: OWB
• UDI-Device Identifier: 00884838099203
• UDI-Public: (01)00884838099203
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2025

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 3 M12
• Device Catalogue Number: 722221
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/05/2025
• Supplement Date Received by Manufacturer: 09/23/2025
• Initial Report FDA Received Date: 08/01/2025
• Supplement Report FDA Received Date: 09/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/06/2021
• 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