MAUDE Adverse Event Report: GE OEC MEDICAL SYSTEMS, INC OEC ELITE CFD; FLUROSCOPIC X-RAY

Model Number	ELITE 31 ECO TOUCH
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Death
Additional Manufacturer Narrative
Ge healthcare's investigation into the reported occurrence, and any potential contribution of the device to the patient outcome, is ongoing.A follow-up report will be submitted when the investigation has been completed.Legal manufacturer: surgery slc: 384 n wright brothers dr usa salt lake city, ut 84116.
Event or Problem Description
On (b)(6) 2026, an internal email originating from a customer site was sent to a ge healthcare (gehc) sales representative indicating that a patient expiration had occurred and that the event was potentially associated with a ge healthcare c arm.The content of the customer¿s email described the following sequence of events: 1.The patient presented for a routine urologic procedure requiring intraoperative fluoroscopy.2.The gehc c arm equipment was maneuvered to obtain the desired view.3.The clinical team did not recognize an image inversion and subsequently requested administration of contrast dye.4.An incorrect dose of contrast dye was administered, which the customer reported as leading to ¿catastrophic outcomes,¿ including a reported patient expiration.No additional information regarding the date of the procedure, specific device settings, images, workflow steps, or any direct observations from gehc personnel has been provided.
Additional Manufacturer Narrative
Ge healthcare has completed its investigation into the reported event.Based on the information provided, the root cause was determined to be use error.The customer reported that "the equipment did not malfunction in this event.The image was reversed inadvertently, and it was unknown to the radiologic technologist at the time." a thorough evaluation of the device, along with a review of available data and customer feedback, did not identify any device malfunction or performance deficiency.There were no ge healthcare¿attributable root causes identified.The risk analysis determined that no additional mitigations are available to reduce the risk, and the risk has been reduced as far as possible.No further actions are planned by ge healthcare.

• Brand Name: OEC ELITE CFD
• Common Device Name: FLUROSCOPIC X-RAY
• Manufacturer (Section D): GE OEC MEDICAL SYSTEMS, INC; 384 n wright brothers; salt lake city UT 84116
• Manufacturer (Section G): GE OEC MEDICAL SYSTEMS, INC; 384 n wright brothers dr; salt lake city, UT 84116
• Manufacturer Contact: troy perry ; 384 wright brothers drive; salt lake city, UT 84116
• MDR Report Key: 24687627
• Report Number: 1720753-2026-00001
• Device Sequence Number: 15884567
• Product Code: OBW
• UDI-Device Identifier: 00840682121729
• UDI-Public: (01)00840682121729(11)251128
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K192819
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/19/2026

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: ELITE 31 ECO TOUCH
• Device Catalogue Number: 00840682121729
• Device Lot Number: FBXXTP00126
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2026
• Supplement Date Received by Manufacturer: 02/24/2026
• Initial Report FDA Received Date: 03/25/2026
• Supplement Report FDA Received Date: 06/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/28/2025
• 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: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown