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

Model Number	AZURION 7 M20
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to philips that the system gave a remote alert, which can impact system geometry movements.No harm was reported to philips.Philips has started an investigation of this complaint.
Additional Manufacturer Narrative
Philips has investigated this complaint.According to the additional information collected, a planned treatment was being performed and was completed by restarting the system with a 3 to 5 minutes of delay due to restart.The philips field service engineer (fse) visited system onsite and confirmed the geometry error.The system logfiles shows errors as remote alert: priority - rmt - pos: programming error: gscrt 000.Upon troubleshooting, the fse found that customer it network experienced a data packet storm due to which the system experienced geometry issues.To resolve the issue, fse instructed customer to operate the system on a stand-alone mode until the customers it network issue get resolved.The system was reconnected to customer's it network upon the it network issue was resolved, after which no errors were observed on the system and the system was returned to use in good working order.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.An additional information concludes that no malfunction with the philips system, the geometry issue occurred due to customers network problem.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: 21897322
• Report Number: 3003768277-2025-003784
• Device Sequence Number: 8097935
• Product Code: OWB
• UDI-Device Identifier: 00884838059191
• UDI-Public: (01)00884838059191(10)1.8
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K181830
• 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): 07/21/2025

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 7 M20
• Device Catalogue Number: 722079
• 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: 03/31/2025
• Supplement Date Received by Manufacturer: 07/16/2025
• Initial Report FDA Received Date: 04/24/2025
• Supplement Report FDA Received Date: 07/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/09/2021
• 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