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	05/31/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to philips that the device's wireless footswitch was not connecting/pairing.The system was in clinical use.No user or patient harm has been reported.A philips field service engineer (fse) visited the site and performed the pairing action again.The device was returned to expected functionality.
Additional Manufacturer Narrative
Philips has investigated this complaint.According to the additional information collected, the system was in clinical use when the issue was identified.The procedure was completed by using wired footswitch.Per the information collected, the wireless footswitch does not connect.Philips has confirmed that battery indicator was in red and wi-fi indicator was off and the reported failure is due to a connectivity issue.To resolve the issue fse re-paired the wireless footswitch, system works as specified post this action.On 05jun2024, the issue re-occurred, and the issue resolved replacing the wireless footswitch.Due to a firmware bug, the wireless foot switch can suddenly stop responding when a number of ambient conditions coexist, such as emc disturbance and the presence of other wireless devices in the room.Philips has initiated a medical device correction (z-0649-2022).The correction has been implemented at the customer and the system was returned to use in good working order.The codes were updated based on the investigation outcome.
Additional Manufacturer Narrative
The event should not have been reported to fda.In the event of a wireless footswitch failure, the handswitch and/or an optional wired footswitch and the are available to command both fluoroscopy and exposure and therefore the function of the system was not lost in addition, the event occurred after implementation of the correction 3003768277-2021/11/22-010-c, and thus the malfunction with the wireless footswitch would not cause or contribute to a serious injury.Specifically, philips installed new firmware, confirmed that a back-up wired footswitch was installed with the system, inspected the wireless foot switch, and provided an updated instructions for use of the system detailing the appropriate instructions on charging and handling the wireless footswitch.Accordingly, the user reported that although there was an issue with the wireless footswitch it was able to successfully complete the procedure.There was no report of harm to the patient.

• 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: 19491394
• Report Number: 3003768277-2024-03238
• Device Sequence Number: 17898582
• 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: Biomedical Engineer
• Remedial Action: Repair
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/06/2025

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?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2024
• Supplement Date Received by Manufacturer: 08/13/2024; 09/24/2024
• Initial Report FDA Received Date: 06/07/2024
• Supplement Report FDA Received Date: 08/19/2024; 02/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/30/2020
• 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