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

Model Number	AZURION 3 M15
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to philips that the system was unable to boot up.The device was outside 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.According to the additional information collected the system was not in clinical use when the issue was identified.A philips field service engineer (fse) was sent to the site to inspect the issue.After reviewing the log, fse found this interruption may have been caused by an unexpected hospital power outage.To resolve the problem, fse restarting system.After restarting the system, the system returned to use in good working order.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 identified that the procedure is completed by using the same system.The ifu recommends performing a cold restart (switching power off and then on again) every day to keep system quality at an acceptable level.Performing a cold restart is likely to restore system functionality, thus allowing the patient to be brought to the room for the procedure to proceed.A situation in which the system will not turn on as expected, but the issue is then resolved by utilizing the design mitigations provided by the device (warm restart or cold restart) is not likely to cause or contribute to death or serious injury if it were to recur.Based on the investigation results, philips concluded that the 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: 23552968
• Report Number: 3003768277-2025-014606
• Device Sequence Number: 9448781
• Product Code: OWB
• UDI-Device Identifier: 00884838099210
• UDI-Public: (01)00884838099210
• Combination Product (Y/N): N
• Initial Reporter Country: EG
• 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): 12/22/2025

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 M15
• Device Catalogue Number: 722222
• 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: 11/05/2025
• Supplement Date Received by Manufacturer: 11/28/2025
• Initial Report FDA Received Date: 11/14/2025
• Supplement Report FDA Received Date: 12/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/30/2021
• 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