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	Poor Quality Image (1408)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/01/2026
Type of Reportable Event	Death
Event or Problem Description
It was initially reported to philips by a hospital staff member that a patient passed away on (b)(6) 2026, and that poor image quality contributed to this outcome.Upon clinical follow-up, philips has received additional information from the institution¿s lab manager stating that while a patient death did occur, it was not related to image quality.The lab manager also requested that the earlier statement provided be disregarded.An investigation into this complaint has been initiated by philips.

• 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: 50174378
• Report Number: 3042175844-2026-002096
• Device Sequence Number: 10035538
• Product Code: OWB
• UDI-Device Identifier: 00884838116771
• UDI-Public: (01)00884838116771
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Type of Report: Initial
• Report Date (Section B): 08/07/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: Azurion 7 M20
• Device Catalogue Number: 722234
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2026
• Initial Report FDA Received Date: 08/07/2026
• Date Device Manufactured: 06/04/2025
• 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
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown