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	06/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to philips that the system was intermittently unable to perform 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 has investigated this complaint.According to additional information acquired, the system was restarted, and after a short delay, the procedure was completed.A philips remote service engineer (rse) reviewed log files, which showed that only low-load fluoroscopy was possible, and cooling unit errors were visible.Upon further inspection, the philips field service engineer (fse) confirmed the reported issue and replaced the cooling unit.After that, the system was returned in good working condition and was ready for clinical use.The cooling unit was returned for further analysis.Functional testing was performed, and a defective flow switch was found.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 function 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 function issue may resolve, allowing for continuation and completion of the procedure.Therefore, if the loss 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 this event to be not reportable.The codes were updated based on the investigation outcome.The fda establishment registration number [fei] has been updated and reported to the fda, changing from 3003768277 to 3042175844, effective december 21, 2025.This change reflects as administrative registration update only.There have been no changes to the registered owner/operator, official correspondent, legal entity name, physical establishment address, manufacturing processes, or to the design, specifications, intended use, or manufacturing processes of any listed devices.

• 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: 22190227
• Report Number: 3003768277-2025-005347
• Device Sequence Number: 8594258
• Product Code: OWB
• UDI-Device Identifier: 00884838116764
• UDI-Public: (01)00884838116764
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2026

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?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2025
• Supplement Date Received by Manufacturer: 03/06/2026
• Initial Report FDA Received Date: 06/11/2025
• Supplement Report FDA Received Date: 03/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/02/2024
• 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