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

Model Number	AZURION 7 B20
Medical Device Problem Code	Radiation Output Failure (4027)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to philips that the system's wireless footswitch was unable to trigger x-rays the device use was unknown at the time of the event.No harm was reported to philips.Philips has started an investigation of this complaint.
Additional Manufacturer Narrative
Philips investigated this complaint.According to additional information collected, the system was in clinical use at the time of event occurrence.The procedure was completed by using wired footswitch.A philips field service engineer (fse) visited the site but could not replicate the issue.It was determined that the footswitch malfunction was due to inadvertent pressing.The problem was resolved by restarting the system.After which, the system was returned to good working order.The failure of wireless footswitch is not attributed to any existing fsca.At the time this complaint was received, philips did not have enough information to exclude a product malfunction with the potential for death or serious injury on recurrence, and as such the complaint was reported.Since that time, new information has been received which has led to the determination that this is scenario is not likely to cause or contribute to death or serious injury if it were to recur.An update has been made to the instructions for use (ifu) regarding the charging and handling of the wireless footswitch.This includes the requirement to have the wired footswitch always connected as a backup.Therefore, due to the availability of an alternative footswitch, in the event of a wireless footswitch failure, the procedure can be completed with minimal or no delay.Due to this, the malfunction of a wireless footswitch would not be likely to lead to a death or serious injury.Based on the investigation results, philips concluded that the complaint is not reportable.The codes have been updated based on the investigation's 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: 23341732
• Report Number: 3003768277-2025-012678
• Device Sequence Number: 7677581
• Product Code: OWB
• UDI-Device Identifier: 00884838116801
• UDI-Public: (01)00884838116801
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2025

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 B20
• Device Catalogue Number: 722236
• 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: 09/25/2025
• Supplement Date Received by Manufacturer: 10/24/2025
• Initial Report FDA Received Date: 10/20/2025
• Supplement Report FDA Received Date: 11/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/16/2025
• 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
• Patient Sex: Unknown