MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. INGENUITY CT; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED

Model Number	INGENUITY ELITE 128
Medical Device Problem Codes	Environmental Particulates (2930); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Unspecified Vascular Problem (4441); Insufficient Information (4580)
Date of Event	10/30/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
We have not completed our investigation of this event.Upon completion, we will submit a follow-up emdr report.Internal cross reference: complaint (b)(4).
Event or Problem Description
Philips received a report indicating that during an interventional cementoplasty procedure, the ct system intermittently generated an error message, interrupting the scan.During the procedure, the error caused the system to close and restart the examination, resulting in a delay in image acquisition.Due to the interruption, a portion of the injected cement could not be adequately visualized and subsequently migrated into the patient¿s inferior vena cava (ivc).
Additional Manufacturer Narrative
The investigation into the exam application error message on the ingenuity ct system determined that loss of visualization occurred after cement injection had already been completed, and the operator appropriately paused the procedure.Post-scan cement detection is a known and documented risk associated with the cementoplasty procedure and is not indicative of a device malfunction.Further investigation identified debris deposition on the slipring as the cause of the application error message.This condition was resolved following a thorough cleaning of all slipring contacts.Based on the investigation findings, there is no evidence that the device caused or contributed to the alleged harm.Therefore, this event does not meet the criteria for reportability, and the reporting determination has been updated to non-reportable.The codes were updated based on the investigation outcome.Device problem, patient outcome, and health impact codes were corrected.

• Brand Name: INGENUITY CT
• Common Device Name: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• 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: john maga ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 23549881
• Report Number: 3015777306-2025-000010
• Device Sequence Number: 15873862
• Product Code: JAK
• UDI-Device Identifier: 00884838059504
• UDI-Public: (01)00884838059504
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K160743
• 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): 01/16/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: INGENUITY ELITE 128
• Device Catalogue Number: 728323
• 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: 11/05/2025
• Supplement Date Received by Manufacturer: 12/17/2025
• Initial Report FDA Received Date: 11/13/2025
• Supplement Report FDA Received Date: 01/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/19/2019
• 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