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	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to philips that the geometry movements were unavailable.The device was in clinical use at the time of the reported event.No harm was reported to philips.Philips has started an investigation of this complaint.
Additional Manufacturer Narrative
Philips has investigated this complaint.The customer was performing a planned/non-emergency treatment at the time of the reported event.The procedure was completed after restarting the system.A philips remote service engineer (rse) connected with the biomed remotely and was notified of an error 'some stand movements are not available'.The rse analyzed the log file and confirmed the reported issue.As the issue was resolved by restarting the system and there were no further errors after that, a root cause could not be determined.The system was returned to use in good working order.There has been no recurrence of this issue reported from 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 has identified that the issue was resolved via restarts, which allowed for procedural continuation.If a loss of function occurs during a procedure, a warm/fast 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 issue may be resolved, allowing for continuation and completion of the procedure.A loss of function that can be resolved by utilizing the design mitigations provided by the device (warm/fast restart or cold restart) is not likely to cause or contribute to death or serious injury if it were to recur and as such philips concludes 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: 21522096
• Report Number: 3003768277-2025-002220
• Device Sequence Number: 9584749
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2025

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 5 M12
• Device Catalogue Number: 722231
• 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: 02/21/2025
• Supplement Date Received by Manufacturer: 10/03/2025
• Initial Report FDA Received Date: 03/05/2025
• Supplement Report FDA Received Date: 10/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/07/2024
• 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