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 Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/27/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to philips that the wireless foot switch lost connection as the wi-fi indicator led stayed red.The device was in clinical use at the time of the event.No harm was reported to philips.Philips has started an investigation of this complaint.
Additional Manufacturer Narrative
Philips has investigated this complaint.According to additional information collected, the diagnosis coronary procedure was completed by using another system.The philips engineer confirmed that there was no issue with wireless footswitch, the issue was with wired footswitch.Upon functional testing, field service engineer(fse) identified that the middle switch was not working.The quote was sent to the customer for repair.However, the quote expired due to no customer response.No service provided by philips.The codes were updated based on the investigation outcome.
Additional Manufacturer Narrative
Corrected narrative: philips has investigated this complaint.According to additional information collected, the diagnosis coronary procedure was completed by using another system.The philips engineer confirmed that there was no issue with wireless footswitch, the issue was with wired footswitch.During functional testing, the field service engineer (fse) identified that the middle switch was not operational.Subsequently, a repair quote was issued to the customer.However, the quote expired due to the customer's lack of response.Consequently, no service was provided by philips.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 have been updated based on the investigation's 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: marjan vos ; plot no. b-79, midc,; phase-ii, chakan; pune 41050-1 ; IN 410501
• MDR Report Key: 21091101
• Report Number: 3003768277-2025-000117
• Device Sequence Number: 9161424
• Product Code: OWB
• UDI-Device Identifier: 00884838091528
• UDI-Public: (01)00884838091528
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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): 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 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: 12/27/2024
• Supplement Date Received by Manufacturer: 03/26/2025; 03/26/2025
• Initial Report FDA Received Date: 01/07/2025
• Supplement Report FDA Received Date: 03/27/2025; 09/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/22/2021
• 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