MAUDE Adverse Event Report: Philips Medical Systems Nederland B.V. Brilliance iCT; System, X-Ray, Tomography, Computed

Model Number	Brilliance iCT
Medical Device Problem Code	Arcing (2583)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/08/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported that the gantry shut down during the arterial phase of a control scan following embolization, resulting in a 30-minute delay.The patient¿s condition had reportedly deteriorated during the waiting period, and the patient was transferred back to the icu (intensive care unit).The scan was subsequently completed several hours later on a different system.No intervention was required during the 30-minute waiting period in the radiology department; however, it remains unknown whether treatment was required after the patient returned to the icu.No permanent impairment was reported, and the patient has recovered.Based on the available information, this issue has been determined to be a reportable event.Philips has started an investigation into this complaint.We will file a follow-up emdr at the completion of the investigation.
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).

• Brand Name: Brilliance iCT
• 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 ; +1(617)245-5900
• MDR Report Key: 50819028
• Report Number: 3015777306-2026-100004
• Device Sequence Number: 10677675
• Product Code: JAK
• UDI-Device Identifier: 00884838059474
• UDI-Public: (01)00884838059474
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K162838
• 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
• Report Date (Section B): 09/18/2026

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: Brilliance iCT
• Device Catalogue Number: 728306
• 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: 09/08/2026
• Initial Report FDA Received Date: 09/18/2026
• Date Device Manufactured: 07/01/2014
• 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