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

Model Number	ZENITION 70
Medical Device Problem Code	Radiation Output Failure (4027)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to philips that the wireless footswitch was defective.No harm was reported to philips.We are conservatively reporting this event as the investigation is ongoing.
Additional Manufacturer Narrative
Philips has investigated this complaint.Philips attempted to schedule having a field service engineer (fse) inspect the system onsite, but the service quotation was not accepted by the customer and the quotation has expired; no device inspection was performed by philips.No further information has been received regarding the event reported.The codes were updated based on the investigation outcome.
Additional Manufacturer Narrative
Philips has investigated this complaint.According to the additional information acquired, the system was outside of use at the time of the reported event.While on site for implementation of fsca 2021-igt-pun-011, the field service engineer (fse) identified that the light emitting diode (leds) on the wireless foot switch (wfs) were defective.To resolve the issue, the wfs was replaced, which also resulted in the implementation of the intended fsca.The system was returned in good working order and ready for clinical use.The wireless foot switch (wfs) was returned for further analysis.Functional testing revealed that the battery indicator did not function as intended.The zenition 70 has been designed to have a built-in redundancy in the form of a handswitch.If the wireless footswitch fails to activate x-rays, then the user can switch to the wired or the handswitch seamlessly to continue and complete the procedure.Hence, the post-market risk assessment indicates that the level of risk remains consistent with the product¿s risk management file for loss of live image as the part is not being monitored.At the time this complaint was received, philips did not have enough information to exclude the potential for death or serious injury on recurrence, and as such the complaint was reported.Since that time, new information has been received which 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.The issue occurred without patient involvement and was identifiable prior to procedure commencement.Alternatively, a second (wired) footswitch and handswitch is also available to use with the system.This scenario is not likely to cause or contribute to death or serious injury if it were to recur.Based on re-evaluation, this case is not reportable.The codes were updated based on the investigation outcome.

• 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 ; veenpluis 6; best 5684 -PC ; NL 5684 PC
• MDR Report Key: 20492161
• Report Number: 3003768277-2024-05963
• Device Sequence Number: 14341132
• Product Code: OWB
• UDI-Device Identifier: 00884838091528
• UDI-Public: 00884838091528
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K183040
• 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): 10/08/2025

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 70
• Device Catalogue Number: 718133
• 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: 10/10/2024
• Supplement Date Received by Manufacturer: 12/19/2024; 12/19/2024
• Initial Report FDA Received Date: 10/21/2024
• Supplement Report FDA Received Date: 01/08/2025; 10/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/19/2019
• 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