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

Model Number	AZURION 7 B12
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Fall (1848)
Date of Event	02/17/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to philips that following a procedure for the insertion of a swan¿ganz catheter, staff were preparing to transfer the sedated patient with a larger build from the table, when the patient unexpectedly partly slid off the tabletop.The staff were using a non-philips mattress (tempur med) with a paper sheet and a slider board that were kept in place from the patient transfer at the start of the procedure.According to the report, the patient sustained a cranial hematoma.The report also stated that the patient later passed away; however, no additional information regarding the incident has been provided to date.An investigation into this complaint has been initiated by philips.
Additional Manufacturer Narrative
The investigation into this complaint remains ongoing; however, the available information indicates that the customer site had experienced similar near miss situations before, and opportunities for strengthening local safety practices and preventive measures were identified during internal review.Leaving the slider in place between the patient and the mattress deviates from intended operating practices and falls outside the reasonable scope of user interface¿related risk controls for the table manufacturer.Therefore, philips concludes that the table did not contribute to the patient outcome.A final report will be provided upon completion of the investigation.The codes have been updated to reflect the new information.

• 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: 24485027
• Report Number: 3003768277-2026-100927
• Device Sequence Number: 21501896
• Product Code: OWB
• UDI-Device Identifier: 00884838099265
• UDI-Public: (01)00884838099265
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 03/17/2026

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 B12
• Device Catalogue Number: 722225
• 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: 02/18/2026
• Supplement Date Received by Manufacturer: 02/27/2026
• Initial Report FDA Received Date: 03/02/2026
• Supplement Report FDA Received Date: 03/17/2026
• Date Device Manufactured: 02/08/2023
• 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 Age: 83 YR
• Patient Sex: Male