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	03/08/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It has been reported to philips that the zenition 50 mobile system footswitch was not available.No harm has been reported.Philips has started an investigation of the complaint.
Additional Manufacturer Narrative
Philips has investigated this complaint.According to the information provided, wired footswitch does not work when it was outside clinical use and footswitch remains in error mode.The philips field service engineer (fse) inspected the system onsite and confirmed that wired footswitch not being available due to be mechanical failure.Fse has confirmed that the reported failure and inspected the system onsite and fse found the connector of wired footswitch was broken.Fse replaced the footswitch.After replacement of the footswitch the system was returned to use in good working order. .

• 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: 16601280
• Report Number: 3003768277-2023-01877
• Device Sequence Number: 15233378
• Product Code: OWB
• UDI-Device Identifier: 00884838091535
• UDI-Public: 00884838091535
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• 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 Health Care Professional
• 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?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2023
• Supplement Date Received by Manufacturer: 08/23/2023
• Initial Report FDA Received Date: 03/23/2023
• Supplement Report FDA Received Date: 09/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/10/2022
• 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