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	03/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to philips that the system's c-arm was unable to move.The device was in clinical use at the time of the event.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 collected, the issue occurred during a treatment procedure.The procedure was completed as planned using the same system, with a delay of less than 20 minutes.It was reported to philips that the c-arm was unable to move, stand stopped moving during the procedure, the table movements were non-functional, and the system displayed a "maquet 12" error.Review of the logfiles shows magnus driver table software version mismatch suggesting that reboot is required to clear the software mismatch.Upon troubleshooting, the philips remote service engineer (rse) checked the system remotely and found that both the c-arm (stand) and the maquet magnus table movements were non-functional, with a "maquet 12 error" displayed.The rse continued troubleshooting and confirmed that the issue is with the maquet table software issue (third-party vendor), and no issue was found with the philips c-arm.To resolve the issue, the hospital¿s biomed engineer, with assistance from maquet, cleared the lock issue on the table.After repairs the device returned to 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 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.A scenario where the geometric functionality is still available and the procedure can be completed on the same system with no or minimum delay, is not likely to cause or contribute to death or serious injury should it recur.Therefore, based on this investigation results, philips concludes that this complaint is not reportable.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: 21759754
• Report Number: 3003768277-2025-003044
• Device Sequence Number: 15575989
• Product Code: OWB
• UDI-Device Identifier: 00884838059191
• UDI-Public: (01)00884838059191(10)1.6.6
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K163715
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2025

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?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2025
• Supplement Date Received by Manufacturer: 06/04/2025
• Initial Report FDA Received Date: 04/03/2025
• Supplement Report FDA Received Date: 06/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/07/2021
• 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