MAUDE Adverse Event Report: PHILIPS INDIA LTD. ZENITION; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Model Number	ZENITION 50
Medical Device Problem Code	Radiation Output Failure (4027)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to philips that the system's footswitch was unable to trigger x-rays, which can impact imaging.The device was in clinical use at the time of the event.No harm to the patient or user was reported.Philips has started an investigation of this complaint.
Additional Manufacturer Narrative
Philips has investigated this complaint.According to the additional information collected, the issue occurred during the procedure.The procedure was completed by using the hand switch.The remote service engineer (rse) analyzed the system remotely and identified that the x-rays did not activate when the footswitch was pressed.Upon troubleshooting actions, rse identified that the connector lock of the wired footswitch was faulty, leading to a loose connection.Customer ordered and replaced the wired footswitch.After replacement, the system was returned to use in good working order.The codes were updated based on the investigation outcome.Component code was corrected.
Additional Manufacturer Narrative
Corrected: additional narrative.Philips has investigated this complaint.According to the additional information collected, the issue occurred during the procedure.The procedure was completed by using the hand switch.The remote service engineer (rse) analyzed the system remotely and identified that the x-rays did not activate when the footswitch was pressed.Upon troubleshooting actions, rse identified that the connector lock of the wired footswitch was faulty, leading to a loose connection.Customer ordered and replaced the wired footswitch.After replacement, the system was returned to use in good working order.Re-evaluation of the reported event has led to the determination that this complaint is not reportable.The issue was confirmed to be with the wired foot switch.The reported issue did not lead to a death or a serious deterioration in the state of health of a patient, user or other person and based on historical data it's unlikely to do so were it to recur.Based on re-evaluation, philips concludes that the complaint is not reportable.The codes were updated based on the investigation outcome.Component code was corrected.

• Brand Name: ZENITION
• 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: 20805757
• Report Number: 3003768277-2024-006910
• Device Sequence Number: 9830821
• Product Code: OWB
• UDI-Device Identifier: 00884838091535
• UDI-Public: (01)00884838091535
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K183101
• 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,Followup
• Report Date (Section B): 09/11/2025

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: ZENITION 50
• Device Catalogue Number: 718096
• 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: 11/14/2024
• Supplement Date Received by Manufacturer: 01/15/2025; 01/15/2025
• Initial Report FDA Received Date: 11/28/2024
• Supplement Report FDA Received Date: 01/24/2025; 09/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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