MAUDE Adverse Event Report: PHILIPS INDIA LTD. ZENITION; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Model Number	ZENITION 50
Medical Device Problem Codes	No Apparent Adverse Event (3189); Radiation Output Failure (4027)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It has been reported to philips that the wireless foot pedal was defective.The device was in clinical use.No harm has been reported to philips.Philips has started an investigation of this complaint.
Additional Manufacturer Narrative
Philips has investigated this allegation.At the time this case was received, philips did not have enough information to exclude the potential for death or serious injury on recurrence, and as such the information was reported.Since that time, it was identified that there was no event, nor malfunction associated with this allegation.The investigation into the reported allegation identified that the customer asked a question regarding wireless footswitch symbols and there was no product problem.The codes were updated based on the investigation outcome.H3 other text : customer had question regarding footswitch & there was no product problem.

• 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: 18048228
• Report Number: 3003768277-2023-05965
• Device Sequence Number: 8041793
• Product Code: OWB
• UDI-Device Identifier: 00884838091535
• UDI-Public: 00884838091535
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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
• 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: 10/23/2023
• Supplement Date Received by Manufacturer: 11/02/2023
• Initial Report FDA Received Date: 11/01/2023
• Supplement Report FDA Received Date: 05/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/28/2020
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown