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	04/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to philips that the wireless footswitch was not working.There was no reported patient or user harm.Due to the lack of information, we are conservatively reporting this event.Philips has started an investigation of this complaint.
Additional Manufacturer Narrative
Philips has investigated this complaint.According to the additional information collected, the system was not in clinical use when the issue occurred.The philips field service engineer (fse) inspected the system onsite and confirmed that the wireless footswitch does not work.Upon functional analysis, it was identified that the wifi indicator was red, and the battery indicator was green.The base station led indicator was in error mode.Fse observed that the wireless base station installed in the unit no longer communicated with the wireless footswitch (wfs).Additionally, there was a mechanical problem in the wireless footswitch.The defective parts were returned to philips for failure analysis.The cause of the wireless base station failure could not be conclusively determined, and the cause of the failure of the wireless footswitch was found to be a loose printed circuit board (pcb) under the pedal; this pcb blocked pedal 3.To resolve the issue, fse replaced the wireless footswitch and the base station.After replacement, the system was returned to good working condition.At the time this complaint was received, philips did not have enough information to exclude a potential for serious injury, and as such, the complaint was reported.Since that time, new information has been received, which has confirmed that the reported failure was related to a mechanical issue in the wireless footswitch and that this event was not associated to any ongoing fsca.As per the instructions for use (ifu), before using the system, the user must check that the wireless foot switch functions with the system.They should ensure that the wireless foot switch is fully operational prior to using it.Alternatively, they could connect a wired foot switch to the auxiliary foot switch connector.Therefore, the mechanical issue would be noticed prior to procedure commencement and alternative measures (such as using the wired footswitch) would be implemented.This has led to the determination that this scenario is not likely to cause or contribute to death or serious injury if it were to recur.Based on the investigation results, philips concludes that the complaint is not reportable.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: 19248333
• Report Number: 3003768277-2024-02604
• Device Sequence Number: 17791749
• Product Code: OWB
• UDI-Device Identifier: 00884838058194
• UDI-Public: 00884838058194
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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
• Report Date (Section B): 09/06/2024

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: 04/12/2024
• Supplement Date Received by Manufacturer: 09/05/2024
• Initial Report FDA Received Date: 05/06/2024
• Supplement Report FDA Received Date: 09/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/09/2019
• 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