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

Model Number	ZENITION 70
Medical Device Problem Code	Radiation Output Failure (4027)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to philips that during a procedure the system produced re-occurring "ma guarding failure" error messages.The procedure was delayed while the customer attempted to restart the system.After the third attempt, the customer brought in a different system to complete the procedure.The report indicated that there was a serious injury; however, no further information regarding the harm has been provided to date.An investigation into this complaint has been initiated by philips.
Additional Manufacturer Narrative
Philips has investigated this complaint.According to the additional information received, the customer was performing a planned non-emergency treatment when the issue occurred.After an inquiry into the serious injury claim in the initial report it was relayed to us by the customer that there was no harm to the patient.A philips field service engineer (fse) inspected the system on site and identified an issue related to the x-ray tube ma (milliampere) output.The system's x-ray tube was replaced, and the system was returned to use in good working order.Re-evaluation of the reported event has led to the determination that this event is not reportable.The reported issue did not lead to a death or a serious deterioration in the state of health of a patient, user or other person and based on historical data it's unlikely to do so were it to recur.Based on re-evaluation, philips concludes that the event as communicated in the complaint is not reportable.The codes have been updated based on investigation outcome.

• 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: 19990607
• Report Number: 3003768277-2024-04449
• Device Sequence Number: 8461455
• Product Code: OWB
• UDI-Device Identifier: 00884838091528
• UDI-Public: 00884838091528
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K183040
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: ZENITION 70
• Device Catalogue Number: 718133
• 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: 08/08/2024
• Supplement Date Received by Manufacturer: 11/12/2024
• Initial Report FDA Received Date: 08/15/2024
• Supplement Report FDA Received Date: 12/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/02/2021
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown