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	09/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to philips that the wireless footswitch does not work.The device was outside of clinical use at the time of the reported event.No harm was reported to philips.Philips has started an investigation of this complaint.
Additional Manufacturer Narrative
Philips has investigated this complaint.Per information collected, the battery and wi-fi indicator was red, which indicates that there was an error in the wireless connection.The customer was using the wired footswitch.The field service engineer (fse) went onsite and confirmed that the footswitch would not work.The fse tried to turn off the foot switch, however, the led remains red, and reconnecting the foot pedal to the base station does not rectify the problem.The philips engineer replaced the wireless foot switch and base station, returned to philips for further analysis.The analysis of footswitch identified paint damaged, and loose bracket.However, the cause of the base station failure cannot be conclusively determined by supplier analysis.After replacement, the system was returned to use in good working order.The codes were updated based on the investigation outcome.
Additional Manufacturer Narrative
The reported event occurred prior to completion of the field correction 3003768277-2021/11/22-010-c, which addresses the causes associated with the reported malfunction.

• 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: 20394841
• Report Number: 3003768277-2024-05738
• Device Sequence Number: 6652197
• Product Code: OWB
• UDI-Device Identifier: 00884838058194
• UDI-Public: 00884838058194
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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): 02/13/2025

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: 09/16/2024
• Supplement Date Received by Manufacturer: 01/15/2025; 09/24/2024
• Initial Report FDA Received Date: 10/08/2024
• Supplement Report FDA Received Date: 02/06/2025; 02/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/29/2018
• 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
• 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