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 Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to philips that the new foot switch could not be connected wirelessly.No harm to the patient or user was reported.Philips has started an investigation of the complaint.
Additional Manufacturer Narrative
Philips has investigated this complaint.According to the information provided, the system was not in clinical use when the issue occurred.The cause of the wireless footswitch failure could not be conclusively determined by the supplier's part analysis.However, upon functional analysis, fse confirmed that the new wireless footswitch no longer connects to the device.The old foot switch started to work after the field change order implementation.Also, the customer loaded the footswitch, which resolved the battery led defect.Based on the available information, the reported problem could not be confirmed.However, as per our records, the system is identified as being part of the unit affected list of medical device correction (z-0647-2022).The correction has been implemented, and the system has been returned to use in good working order.The codes were updated based on the investigation outcome.
Additional Manufacturer Narrative
The reported event occurred prior to completion of the field correction 3003768277-2021/11/22-010-c, which addresses the causes associated with the reported malfunction.

• 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 ; plot no. b-79, midc,; phase-ii, chakan; pune 41050-1 ; IN 410501
• MDR Report Key: 18148310
• Report Number: 3003768277-2023-06310
• Device Sequence Number: 6875281
• Product Code: OWB
• UDI-Device Identifier: 00884838091535
• UDI-Public: 00884838091535
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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
• 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: 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: 11/07/2023
• Supplement Date Received by Manufacturer: 02/29/2024; 09/24/2024
• Initial Report FDA Received Date: 11/16/2023
• Supplement Report FDA Received Date: 03/05/2024; 02/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/19/2020
• 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