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	Radiation Output Failure (4027)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to philips that the system failed to expose.The device was in clinical use at the time of the reported event.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 issue occurred during a coronary diagnosis procedure.The procedure got aborted and the exam was performed on another day.The philips field service engineer (fse) inspected the system onsite and confirmed that the system failed to expose.The fse checked the logfile which was indicating power inverter error.The fse discussed the situation with the national support specialist (nss) and the nss recommended for reseat connections on x-ray segment controller (xsc) and perform tube conditioning as a preventative measure.To resolve the issue, the fse performed frontal tube adaptation and calibration and entrance dose limit (edl) calibration.After all calibrations, the system was returned to use in good working order.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: 22135799
• Report Number: 3003768277-2025-005002
• Device Sequence Number: 12854830
• Product Code: OWB
• UDI-Device Identifier: 00884838101890
• UDI-Public: (01)00884838101890
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K172822
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/04/2025

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 7 M12
• Device Catalogue Number: 722078
• 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: 05/27/2025
• Supplement Date Received by Manufacturer: 06/11/2025
• Initial Report FDA Received Date: 06/03/2025
• Supplement Report FDA Received Date: 07/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/06/2020
• 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