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	08/15/2024
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.A follow up report will be submitted when further information is received.Philips has started an investigation of this complaint.
Additional Manufacturer Narrative
Philips has investigated this complaint.According to additional information collected, system was outside of clinical use at the time of event.The connection was not re-established, and the customer was using the wired footswitch.The philips field service engineer (fse) visited onsite and found an issue with the wireless footswitch battery.To resolve the issue, fse replaced the wireless footswitch.After replacement the system was returned to work in good working condition.At the time this complaint was received, philips did not have enough information to exclude a potential for serious injury, and as such, the complaint was reported.Since that time, new information has been received, which has confirmed that the reported failure was related to a battery issue in the wireless footswitch.As per the instructions for use (ifu), before using the system, the user must check that the wireless foot switch functions with the system.They should ensure that the battery of the wireless foot switch is fully charged prior to using it and take care not to damage the cable of the charger when moving equipment around the examination room (for example, when moving carts or beds).Alternatively, they could connect a wired foot switch to the auxiliary foot switch connector.Therefore, the battery issue would be noticed prior to procedure commencement and alternative measures (such as using the wired footswitch) would be implemented.This 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.Based on the investigation results, philips concludes that the complaint 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 ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 20076738
• Report Number: 3003768277-2024-04736
• Device Sequence Number: 6537194
• Product Code: OWB
• UDI-Device Identifier: 00884838091528
• UDI-Public: 00884838091528
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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
• Report Date (Section B): 02/03/2025

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: 08/15/2024
• Supplement Date Received by Manufacturer: 01/28/2025
• Initial Report FDA Received Date: 08/27/2024
• Supplement Report FDA Received Date: 02/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/13/2019
• 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