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	11/14/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to philips that the system's wired footswitch stopped responding, which can impact imaging.The device was in clinical use at the time of reported event.No harm was reported to philips.Philips has started an investigation of this complaint.
Additional Manufacturer Narrative
Correction report: rdn corrected.Philips has investigated this complaint.According to the additional information collected, the vascular diagnosis procedure was performed when the issue happened, and procedure was completed by using the wireless footswitch.The philips remote service engineer (rse) connected with the customer and examined the system remotely and found wired footswitch stopped responding.Customer confirmed fault with wired footswitch.The cause of the footswitch failure could be determined by the supplier's part analysis, and it misses anti-slip, loose bracket, and footswitch failed.To resolve the issue, rse ordered wired footswitch and the customer replaced it.After replacement of wired footswitch, system returned to good working condition.At this time of the event philips did not have enough information to exclude the potential for death or serious injury on recurrence, and as such the complaint was reported.Since that time, new information has identified that the issue is resolved by using the wireless footswitch.The device has no issue, procedure was completed as planned.This event would not be reportable.The codes were updated based on the investigation outcome.
Additional Manufacturer Narrative
Philips has investigated this complaint.According to the additional information collected, the vascular diagnosis procedure was performed when the issue happened, and procedure was completed by using the wireless footswitch.The philips remote service engineer (rse) connected with the customer and examined the system remotely and found wired footswitch stopped responding.Customer confirmed fault with wired footswitch.The cause of the footswitch failure could be determined by the supplier's part analysis, and it misses anti-slip, loose bracket, and footswitch failed.To resolve the issue, rse ordered wired footswitch and the customer replaced it.After replacement of wired footswitch, system returned to good working condition.At this time of the event philips did not have enough information to exclude the potential for death or serious injury on recurrence, and as such the complaint was reported.Since that time, new information has identified that the issue is resolved by using the wired footswitch.The device has no issue, procedure was completed as planned.This event would not be reportable.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: derrick massuri ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 20842722
• Report Number: 3003768277-2024-007029
• Device Sequence Number: 8039413
• Product Code: OWB
• UDI-Device Identifier: 00884838064775
• UDI-Public: (01)00884838064775(10)225
• Combination Product (Y/N): N
• Initial Reporter State: WY
• 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: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/18/2025

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: 722068
• 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: 11/14/2024
• Supplement Date Received by Manufacturer: 02/15/2025; 02/15/2025
• Initial Report FDA Received Date: 12/04/2024
• Supplement Report FDA Received Date: 02/18/2025; 02/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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