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

Model Number	AZURION 5 M20
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to philips that the system was unable to perform 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, the system was not in clinical use at the time of the event.The philips field service engineer (fse) inspected the system on-site and confirmed that the system was unable to perform geometry movements.Upon troubleshooting, the fse found that the issue had occurred during system installation.The fse identified that the clea ceil c-arm and prop box had been switched off, as there was no marking or label to identify it.To resolve the issue, the fse switched it on and uploaded the required software.After that, 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 the potential for death or serious injury on recurrence, and as such, the complaint was reported.Since that time, it has been identified that the issue occurred without patient involvement and was identifiable prior to procedure commencement, which has led to the determination that this scenario is not likely to cause or contribute to death or serious injury if it were to recur.As per the instructions for use, the user of the product must institute a user routine checks program.The user of the product shall ensure that all checks and actions have been satisfactorily completed before using the product for its intended purpose.It is instructed to not use the product for any application until the user is sure that the user routine checks have been satisfactorily completed; therefore, as the device was not in use at the time the issue was identified, the user would identify this issue prior to use, and the issue happened due to improper maintenance.Based on re-evaluation, this case is not reportable.The codes were updated based on the investigation outcome.Evaluation method code was corrected.

• 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: 22422839
• Report Number: 3003768277-2025-006115
• Device Sequence Number: 15217160
• Product Code: OWB
• UDI-Device Identifier: 00884838116757
• UDI-Public: (01)00884838116757
• Combination Product (Y/N): N
• Initial Reporter Country: MO
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2025

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 M20
• Device Catalogue Number: 722232
• 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: 06/25/2025
• Supplement Date Received by Manufacturer: 08/24/2025
• Initial Report FDA Received Date: 07/07/2025
• Supplement Report FDA Received Date: 09/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/22/2025
• 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