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	04/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It has been reported to philips that the wireless footswitch failed to connect to the system.The system was in clinical use when this occurred.There was no report of harm.
Additional Manufacturer Narrative
Philips has investigated the complaint.According to the additional information collected, the issue occurred during a planned diagnosis procedure and was completed using wired footswitch.Based on the information provided, the root cause is most likely caused by local circumstances or a hardware defect.Philips has not been able to determine the cause of the reported problem.Philips confirmed that there was a connection problem between the wireless footswitch and wireless base station.There are two generations of wireless footswitches and base stations.The newest generation has a software bug which can cause loss of wireless connection, and philips initiated medical device correction z-0476-2022 for this generation.This complaint is related to the previous generation of the wireless footswitch which is not affected by the software bug.The fse replaced the wireless footswitch and wireless footswitch base station.After replacement of the wireless footswitch and wireless footswitch base station, the system was returned to use in good working order.The customer has a wired footswitch available for use.The codes were updated based on the investigation outcome.Evaluation method code was corrected.

• Brand Name: ZENITION
• Common Device Name: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; veenpluis 6; best 5684 PC; NL 5684 PC
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; veenpluis 6; best 5684 PC; NL 5684 PC
• Manufacturer Contact: dusty leppert ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 16868223
• Report Number: 3003768277-2023-02685
• Device Sequence Number: 5944494
• Product Code: OWB
• UDI-Device Identifier: 00884838091535
• UDI-Public: 00884838091535
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• 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
• Type of Report: Initial,Followup

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: 04/28/2023
• Supplement Date Received by Manufacturer: 09/01/2023
• Initial Report FDA Received Date: 05/04/2023
• Supplement Report FDA Received Date: 09/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/02/2021
• 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