MAUDE Adverse Event Report: PHILIPS INDIA LTD. 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	01/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to philips that the system's footswitch was unable to connect wirelessly.The system was not in clinical use at the time of the event.No harm was reported to philips.
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 was unable to pair.Upon troubleshooting, the investigation revealed that the wi-fi signal was indicating a red status, and the battery was flashing green.Despite following the troubleshooting procedures outlined in the manual, the fse was unable to establish a stable connection using the current equipment.To resolve the issue, the fse then replaced the wireless footswitch and the base station.The defective wfs base station was returned to philips for failure analysis.The cause of the wfs base station failure could not be conclusively determined by the supplier's part analysis; however, the replacement of the wfs base station and wireless footswitch by the field service engineer has resolved the issue.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 the potential for death or serious injury upon recurrence, and as such, the complaint was reported.Since that time, it has been identified that the issue occurred without patient involvement and was identifiable prior to procedure commencement, which 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.As per the instructions for use, the user of the product must institute a user routine checks program.The user of the product should ensure that all checks and actions have been satisfactorily completed before using the product for its intended purpose.It is instructed not to use the product for any application until the user is sure that their routine checks have been satisfactorily completed.Therefore, as the device was not in use at the time the issue was identified, the user would identify this issue prior to use.Based on re-evaluation, this case 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 INDIA LTD.; plot no. b-79, midc,; phase-ii, chakan; pune 41050 1; IN 410501
• Manufacturer (Section G): PHILIPS INDIA LTD.; plot no. b-79, midc,; phase-ii, chakan; pune 41050 1; IN 410501
• Manufacturer Contact: marjan vos ; plot no. b-79, midc,; phase-ii, chakan; pune 41050-1 ; IN 410501
• MDR Report Key: 21334070
• Report Number: 3003768277-2025-001170
• Device Sequence Number: 8431820
• Product Code: OWB
• UDI-Device Identifier: 00884838058194
• UDI-Public: (01)00884838058194
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 06/04/2025

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: 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: 01/13/2025
• Supplement Date Received by Manufacturer: 06/03/2025
• Initial Report FDA Received Date: 02/07/2025
• Supplement Report FDA Received Date: 06/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/25/2019
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown