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

Model Number	AZURION 7 M12
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Codes	Cardiac Arrest (1762); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to philips that during an emergent coronary angiography, while the table was tilted, the patient required cardiopulmonary resuscitation (cpr).At the physician¿s request, cpr was temporarily paused to allow imaging of the coronary arteries.When an attempt was made to reposition the table, it began to free float.According to the report, assessment of the patient¿s coronary artery status was not possible because disengaging the table motor would have required restarting the system and re-establishing the imaging table geometry, during which cpr could not have been performed.Cpr resumed, and two nurses manually held the table in position.The report further indicated that the patient passed away; however, no additional details have been provided to date.An investigation into this complaint has been initiated by philips.
Additional Manufacturer Narrative
Philips has received additional information regarding the reported event.According to the head physician at the customer site, the patient passed away due to a myocardial infarction, and the system did not contribute to the patient outcome.The investigation into this complaint remains ongoing, and a final report will be provided upon completion.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: 24307257
• Report Number: 3003768277-2026-100650
• Device Sequence Number: 14768786
• Product Code: OWB
• UDI-Device Identifier: 00884838085251
• UDI-Public: (01)00884838085251
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/23/2026

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 M12
• Device Catalogue Number: 722078
• 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: 02/03/2026
• Supplement Date Received by Manufacturer: 02/12/2026
• Initial Report FDA Received Date: 02/10/2026
• Supplement Report FDA Received Date: 02/23/2026
• Date Device Manufactured: 06/20/2018
• 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