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	02/28/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to philips that the wireless footswitch base station was defective.The system was not in clinical use.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 onsite and confirmed that the wireless footswitch base station was defective and needed a new receiver for foot pedal.Upon further inspection, it was confirmed that the battery indicator was green and wi-fi indicator was red.Later, fse confirmed that the wireless footswitch has mechanical issue.Fse replaced the wireless footswitch.After replacing the wireless footswitch, 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: 18855270
• Report Number: 3003768277-2024-01586
• Device Sequence Number: 14281290
• Product Code: OWB
• UDI-Device Identifier: 00884838058194
• UDI-Public: 00884838058194
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup

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: 02/28/2024
• Supplement Date Received by Manufacturer: 04/24/2024
• Initial Report FDA Received Date: 03/07/2024
• Supplement Report FDA Received Date: 04/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/05/2018
• 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