MAUDE Adverse Event Report: SAMSUNG ELECTRONICS CO., LTD. GC85; DIGITIAL DIAGNOSTIC X-RAY SYSTEM

Model Number	GC85A
Medical Device Problem Code	Unintended Electrical Shock (4018)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/15/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The ct technician received static shock when pressing a button on the right side stand control panel for the system.
Additional Manufacturer Narrative
No injury was reported by the employee.We have investigated the issue and measured resistance to be in the acceptable range.No shocks were reported on the system by other x-ray techs after this initial one.We will continue working to determine the root cause of the issue and working on implementing corrective measures to mitigate the risk.Any additional information received on this incident will be reported in a follow-up mdr.

• Brand Name: GC85
• Common Device Name: DIGITIAL DIAGNOSTIC X-RAY SYSTEM
• Manufacturer (Section D): SAMSUNG ELECTRONICS CO., LTD.; 129, samsung-ro; yeongtong-gu; suwon-si, gyeonggi-do 16677 ; KS 16677
• MDR Report Key: 21545159
• Report Number: 3004938766-2025-00009
• Device Sequence Number: 7688120
• Product Code: KPR
• UDI-Device Identifier: 08806088565231
• UDI-Public: 08806088565231
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/06/2025

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?: No
• Device Model Number: GC85A
• Was Device Available for Evaluation?: No
• Device Age: 8 YR
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/07/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown