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	03/07/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to philips that the wireless foot switch lost its connection.The system was in clinical use.No user or patient harm has been reported.A philips field service engineer (fse) visited the site and replaced the wireless foot switch.The device was returned to expected functionality.
Additional Manufacturer Narrative
Philips has investigated this complaint.According to the additional information collected, the planned non-emergency procedure was completed using the wired footswitch.There was no indication on the wi-fi (led) and the battery, and the base station was green.A philips field service engineer (fse) inspected the system onsite and identified that there was a wireless footswitch (wfs) connection problem.The fse replaced the wireless footswitch (wfs) and the wfs base station to resolve the issue.A failure analysis test was performed on both the wfs and the wfs base station.The tests determined that there were no issues with the base station.All four anti slip rubbers in the footswitch are missing.The exact cause of this inability could not be definitively identified.Nonetheless, after the necessary replacements were made, the system was returned to use in good working order.The investigation determined that this malfunction is not connected to any field safety corrective action.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: derrick massuri ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 19277065
• Report Number: 3003768277-2024-02678
• Device Sequence Number: 17722272
• Product Code: OWB
• UDI-Device Identifier: 00884838058194
• UDI-Public: 00884838058194
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2024

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?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2024
• Supplement Date Received by Manufacturer: 09/16/2024
• Initial Report FDA Received Date: 05/09/2024
• Supplement Report FDA Received Date: 09/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/21/2018
• 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