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	04/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to philips that the wireless foot switch was not working.The system was in clinical use.No user or patient harm was reported.A philips field service engineer (fse) visited the site and replaced the wireless foot switch base station and was able to pair with 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 system was during the planned/non-emergency treatment.The treatment was completed by using wired footswitch.The philips field service engineer (fse) examined the system onsite and confirmed that wireless footswitch was not working.Upon troubleshooting, fse found that base station was not compatible with the footswitch.To resolve the issue, fse replaced the base station.After replacement, the system was returned to use in good working order.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: 19229262
• Report Number: 3003768277-2024-02556
• Device Sequence Number: 6892064
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2024

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2024
• Supplement Date Received by Manufacturer: 08/30/2024
• Initial Report FDA Received Date: 05/02/2024
• Supplement Report FDA Received Date: 09/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/23/2018
• 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