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	06/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to philips that the wireless foot switch stopped working.The system was in clinical use at the time of the reported event.No user or patient harm has been reported.To date, no further information was received.We are conservatively reporting this event as the investigation is ongoing.A follow up report will be submitted when further information is received.
Additional Manufacturer Narrative
Philips has investigated this complaint.According to the additional information collected, a planned treatment procedure was performed when the issue happened, and procedure was completed by using wired footswitch.A philips field service engineer (fse) inspected the system and confirmed the wireless footswitch stopped working.Fse confirmed that wi-fi indicator was in red, base station indicator was blinking in yellow and the battery indicator was in green, and the problem is with wireless connection loses intermittently.To resolve the issue, fse replaced the wireless footswitch.Intermittently the wireless connection between the base station and wireless footswitch is lost and the base station or footswitch remains in error mode.When the base station or footswitch is in error mode it blocks x-ray switching functions by means of the wireless footswitch.Other options like the wired footswitch or hand switch can still be used when available.Philips has initiated a medical device correction by providing customers with a medical device correction (z-2485-2023).The codes were updated based on the investigation outcome.
Additional Manufacturer Narrative
The event should not have been reported to fda.The event occurred after implementation of the correction 3003768277-2021/11/22-010-c, and thus the malfunction with the wireless footswitch would not cause or contribute to a serious injury because the system was equipped with a backup wired footswitch.Specifically, philips installed new firmware, confirmed that a back-up wired footswitch was installed with the system, inspected the wireless foot switch, and provided an updated instructions for use of the system detailing the appropriate instructions on charging and handling the wireless footswitch.Moreover, there was no report of harm.

• 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: derrick massuri ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 19534984
• Report Number: 3003768277-2024-03326
• Device Sequence Number: 8541125
• Product Code: OWB
• UDI-Device Identifier: 00884838058194
• UDI-Public: 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
• Remedial Action: Repair
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/06/2025

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: 06/05/2024
• Supplement Date Received by Manufacturer: 09/16/2024; 09/24/2024
• Initial Report FDA Received Date: 06/14/2024
• Supplement Report FDA Received Date: 09/17/2024; 02/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/30/2020
• 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: 3003768277-2021/11/22-01
• Patient Sequence Number: 1
• Patient Sex: Unknown