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	01/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It has been reported to philips that the system could not access x-ray generator, which can impact imaging.The device was in use at the time of reported event.No harm was reported to philips.Philips has started an investigation of this complaint.
Additional Manufacturer Narrative
Philips investigated this complaint.Based on the additional information collected, the system was being used for planned coronary treatment.The procedure was completed after restarting the system, resulting in a delay of less than 20 minutes.The philips fse inspected the system on site and confirmed the reported issue.A review of the log file showed that the system could not access the x ray generator.Upon troubleshooting, the fse found a generator connection error, as there was no communication with the generator.The issue was resolved after performing a complete cold restart.The system was then returned to use in good working conditions.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 cold restart 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 investigation outcomes.

• 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: 24131334
• Report Number: 3003768277-2026-100313
• Device Sequence Number: 5455445
• Product Code: OWB
• UDI-Device Identifier: 00884838116764
• UDI-Public: (01)00884838116764
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• 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): 03/20/2026

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2026
• Supplement Date Received by Manufacturer: 03/18/2026
• Initial Report FDA Received Date: 01/21/2026
• Supplement Report FDA Received Date: 03/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/12/2024
• 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