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	10/31/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to philips that there was a connection issue with the wireless footswitch.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 customer was performing electro-physiology (cardiac arrhythmia, lead management), which was completed by using the wired foot-switch.The philips field service engineer (fse) inspected the system onsite and confirmed that the wireless foot-switch was unable to connect with the base station.Upon troubleshooting, fse identified that the wireless foot-switch battery indicator was in red-green and steady and would not turn off or change with the power switch / charging cable, the wi-fi indicator was off.To resolve the issue, fse removed and then re-installed the battery.After 5 minutes, the system was restarted.After that, the system was returned to good working condition.At the time this complaint was received, philips did not have enough information to exclude a potential for serious injury, and as such, the complaint was reported.Since that time, new information has been received, which has confirmed that the reported failure was related to a battery issue in the wireless foot-switch and that this event was not associated with any ongoing fsca.As per the instructions for use (ifu), before using the system, the user must check that the wireless foot switch functions with the system.They should ensure that the battery for the wireless foot switch is working properly prior to using it, and take care not to damage the cable of the charger when moving equipment around the examination room (for example, when moving carts or beds).Alternatively, they could connect a wired foot switch to the auxiliary foot switch connector.Therefore, the battery issue would be noticed prior to procedure commencement and alternative measures (such as using the wired foot-switch) would be implemented.This has led to the determination that this scenario is not likely to cause or contribute to death or serious injury if it were to recur.Based on the investigation results, philips concludes that the complaint is not reportable.The codes were updated based on the investigation outcome.Evaluation method code was corrected.
Additional Manufacturer Narrative
The reported event occurred prior to completion of the field correction 3003768277-12/28/2023-010-c, which addresses the causes associated with the reported malfunction.

• 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: 20781529
• Report Number: 3003768277-2024-006805
• Device Sequence Number: 5052577
• Product Code: OWB
• UDI-Device Identifier: 00884838101883
• UDI-Public: (01)00884838101883
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Remedial Action: Repair
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/24/2025

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/31/2024
• Supplement Date Received by Manufacturer: 01/06/2025; 09/24/2024
• Initial Report FDA Received Date: 11/26/2024
• Supplement Report FDA Received Date: 01/22/2025; 03/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/24/2019
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 3003768277-12/28/2023-01
• Patient Sequence Number: 1
• Patient Sex: Unknown