MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. 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	09/09/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It has been reported to philips that the wireless footswitch has not been working since installation.A system restart was performed to reset the base station, however the connection has not been re-established.No harm has been reported to philips.Philips has started an investigation of this complaint.
Additional Manufacturer Narrative
Section e: initial reporter corrected.
Additional Manufacturer Narrative
Philips has investigated this complaint.As per the information collected, the wireless footswitch had never been used.It did not work since installation approximately 6 months prior.The system was not in clinical use when the issue was identified.Philips has confirmed that the reported failure is due to a connectivity issue.Due to a firmware bug, the wireless foot switch can suddenly stop responding when a number of ambient conditions coexist, such as emc disturbance and the presence of other wireless devices in the room.Philips has initiated a medical device correction (2021-igt-pun-011).The customer has a wired footswitch available for use.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 MEDICAL SYSTEMS NEDERLAND B.V.; veenpluis 4-6; best 5684 PC; NL 5684 PC
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; veenpluis 4-6; best 5684 PC; NL 5684 PC
• Manufacturer Contact: dusty leppert ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 15566684
• Report Number: 3003768277-2022-00463
• Device Sequence Number: 6158521
• Product Code: OWB
• UDI-Device Identifier: 00884838091535
• UDI-Public: 00884838091535
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Repair
• Type of Report: Initial,Followup,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: 09/09/2022
• Supplement Date Received by Manufacturer: 09/09/2022; 09/09/2022; 09/24/2024
• Initial Report FDA Received Date: 10/07/2022
• Supplement Report FDA Received Date: 11/03/2022; 11/18/2022; 02/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/20/2020
• 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