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

Model Number	ZENITION 70
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Radiation Output Failure (4027)
Health Effect - Clinical Codes	Loss of consciousness (2418); Unspecified Gastrointestinal Problem (4491); Insufficient Information (4580)
Date of Event	07/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to philips that during a fluoroscopy examination, the system lost functionality.The customer rebooted the system multiple times without resolving the issue.The patient was later moved to another room to complete the procedure.It was reported to philips that the delay in completion of the medical procedure may have contributed to the poor outcome of the entire procedure; however, no further details have been provided as of the date of this initial report.Philips has started an investigation of this complaint.
Additional Manufacturer Narrative
Philips investigated this complaint.According to the additional information acquired, the customer was performing an emergency endoscopy procedure.The customer reported that there was a delay in patient care, and that the patient was unconscious and intubated and placed in intensive care.A philips field service engineer inspected the system on site and system log files were analyzed.Investigation identified that the loss of system functionality was due to a failure of the energy storage unit (esu) battery.After replacement of the esu battery, the system was returned to use in good working order.Philips has completed a good faith effort to acquire further information on the reported incident and the patient outcome.However, the customer has not provided the requested information.As philips has not received any further information about the reported incident and the patient outcome, philips is unable to determine whether the philips system caused or contributed to the reported patient harm.
Additional Manufacturer Narrative
Philips has further investigated this complaint.An additional review of the clinical case and medical literature was carried out.The review identified that there are three different types of emergency procedures where endoscopy is performed with fluoroscopy imaging: gastrointestinal bleeding, acute cholangitis/acute biliary pancreatitis, and foreign body ingestion.For all three types of procedures, it was concluded based on medical literature research that, as the procedure was completed on a different system, the likelihood of serious injury due to the delay in an emergency endoscopy was remote.At the time this complaint was received, philips did not have enough information to exclude the potential for serious injury, and the complaint was reported.Since then, new reviews have confirmed that the delay in treatment would not lead to a serious injury event.Therefore, philips has reevaluated this complaint as not reportable.Corrected data: adverse event/product problem.
Additional Manufacturer Narrative
Philips has further investigated this complaint.An additional review of the clinical case and medical literature was carried out.The review identified that there are three different types of emergency procedures where endoscopy is performed with fluoroscopy imaging: gastrointestinal bleeding, acute cholangitis/acute biliary pancreatitis, and foreign body ingestion.For all three types of procedures, it was concluded based on medical literature research that, as the procedure was completed on a different system, the likelihood of serious injury due to the delay in an emergency endoscopy was remote.At the time this complaint was received, philips did not have enough information to exclude the potential for serious injury, and the complaint was reported.Since then, new reviews have confirmed that the delay in treatment would not lead to a serious injury event.Therefore, philips has reevaluated this complaint as not reportable.(device) problem code grid, patient outcome code grid , health impact code was corrected.Corrected data: adverse event/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: 19780343
• Report Number: 3003768277-2024-03960
• Device Sequence Number: 8115334
• Product Code: OWB
• UDI-Device Identifier: 00884838091528
• UDI-Public: 00884838091528
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/10/2025

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2024
• Supplement Date Received by Manufacturer: 01/14/2025; 01/14/2025; 01/14/2025
• Initial Report FDA Received Date: 07/19/2024
• Supplement Report FDA Received Date: 01/15/2025; 02/09/2025; 02/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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