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	05/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to philips that the wireless footswitch lost connection with the wireless base station.The system was not in clinical use.No harm to the patient or user was reported.Philips has started an investigation regarding the reported issue.
Additional Manufacturer Narrative
Philips has investigated this complaint.The philips field service engineer (fse) examined the system onsite and confirmed that the wireless footswitch does not connect.Upon functional analysis, it was identified that the wi-fi indicator was off, and the battery indicator was in green.To resolve the issue, fse replaced the wireless footswitch and the base station.The defective parts were returned to philips for failure analysis, and the cause of the failure of the wireless base station could not be conclusively determined, and failure analysis of the wireless footswitch showed all four anti-slip rubbers were gone.This event is not associated with any of the existing medical device correction.After replacement, the system was returned to good working condition.The codes were updated based on the investigation outcome.
Additional Manufacturer Narrative
The event should not have been reported to fda.The event occurred after implementation of the correction 3003768277-2021/11/22-010-c, and thus the malfunction with the wireless footswitch would not cause or contribute to a serious injury because the system was equipped with a backup wired footswitch.Specifically, philips installed new firmware, confirmed that a back-up wired footswitch was installed with the system, inspected the wireless foot switch, and provided an updated instructions for use of the system detailing the appropriate instructions on charging and handling the wireless footswitch.Moreover, there was no report of harm as the wireless footswitch issue occurred outside of clinical use.

• 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: 19335091
• Report Number: 3003768277-2024-02837
• Device Sequence Number: 3009729
• Product Code: OWB
• UDI-Device Identifier: 00884838091535
• UDI-Public: 00884838091535
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Biomedical Engineer
• 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?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2024
• Supplement Date Received by Manufacturer: 09/16/2024; 09/24/2024
• Initial Report FDA Received Date: 05/16/2024
• Supplement Report FDA Received Date: 10/04/2024; 02/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/26/2019
• 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
• 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