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

Model Number	VERADIUS UNITY
Medical Device Problem Code	Radiation Output Failure (4027)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to philips that the system's footswitch charger was unable to charge.The device was outside of use at the time of reported event.No harm was reported to philips.Philips has started an investigation of this complaint.
Additional Manufacturer Narrative
Philips has investigated this complaint.The philips field service engineer (fse) inspected the system on-site and found that the wireless footswitch charger did not work.Upon troubleshooting, the fse observed that the wireless footswitch was unable to charge.It was identified that the led on the footswitch charger was off.To resolve the issue, the fse replaced the wireless footswitch charger.The defective wireless footswitch charger was returned to philips for failure analysis.The failure analysis confirmed that the female connector was pushed inside.After the replacement, the system was returned to use in good working order.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 footswitch 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 of the wireless foot switch is fully charged prior to using it and take care not to damage the charger cable 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 before 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.

• Brand Name: VERADIUS
• 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: 21459624
• Report Number: 3003768277-2025-001991
• Device Sequence Number: 15364020
• Product Code: OWB
• UDI-Device Identifier: 00884838058194
• UDI-Public: (01)00884838058194
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K142708
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 04/14/2025

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: VERADIUS UNITY
• Device Catalogue Number: 718132
• 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: 01/30/2025
• Supplement Date Received by Manufacturer: 04/08/2025
• Initial Report FDA Received Date: 02/25/2025
• Supplement Report FDA Received Date: 04/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/26/2017
• 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