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	Image Orientation Incorrect (1305)
Health Effect - Clinical Codes	Ischemia (1942); Insufficient Information (4580)
Date of Event	07/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after an st-elevation myocardial infarction (stemi) patient was positioned on the table, prepped, sedated, and vascular access was obtained, fluoroscopy was initiated.At that time, the images were observed to be displayed in reverse ("backwards").The user restarted the system; however, the issue persisted.The patient was subsequently transferred to another facility where the procedure was completed.The patient reportedly remained stable.An investigation into the reported event 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: 50097325
• Report Number: 3003768277-2026-101280
• Device Sequence Number: 10368618
• Product Code: OWB
• UDI-Device Identifier: 00884838116771
• UDI-Public: (01)00884838116771
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 07/31/2026

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
• 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: 07/01/2026
• Initial Report FDA Received Date: 07/31/2026
• Date Device Manufactured: 05/19/2025
• 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: Other
• Patient Sex: Unknown