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

Model Number	AZURION 5 M12
Medical Device Problem Code	Radiation Output Failure (4027)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to philips that there was an issue with the system's collimator, 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 acquired, the system was in clinical use at the time of the event.The procedure was completed after performing a warm restart.A field service engineer (fse) inspected the system on-site.The fse analyzed the log file and confirmed one occurrence of a collimator-related issue during the month of may, which was resolved by restarting the system, with no further errors afterward.The fse checked the functioning of the collimator and did not identify any issues.The collimator errors could not be reproduced; therefore, a root cause could not be determined.The system was returned to use in good working order and is ready for clinical use.To date, there has been no recurrence of this issue reported by the customer.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 was received that identified that the issue was resolved by restarting the system.If a loss of imaging occurs during a procedure, a warm restart or a cold restart may be performed in an attempt to resolve the issue.By using these mitigations provided by the design of the device, the loss of imaging may resolve, allowing for continuation and completion of the procedure.Therefore, if the loss of imaging function is restored with one warm or cold restart and the procedure is completed, it is unlikely that the issue would result in a death or serious injury.Philips has therefore concluded that this event 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: 22025327
• Report Number: 3003768277-2025-004437
• Device Sequence Number: 18442007
• Product Code: OWB
• UDI-Device Identifier: 00884838116740
• UDI-Public: (01)00884838116740
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 01/20/2026

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 5 M12
• Device Catalogue Number: 722231
• 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: 05/05/2025
• Supplement Date Received by Manufacturer: 01/20/2026
• Initial Report FDA Received Date: 05/15/2025
• Supplement Report FDA Received Date: 01/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/13/2024
• 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