MAUDE Adverse Event Report: SAMSUNG ELECTRONICS CO., LTD. GM85

Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The potential patient treatment delay happened as the system was unable to scan.No repeat imaging was necessary.We've implemented corrective measures to mitigate risks and prevent errors.Daily calibration and quality assurance testing on the system were completed without any issues.No patient harm or other issues were reported.
Event or Problem Description
The system shuts down during exams, which caused a delay in the patient's treatment.

• Brand Name: GM85
• Common Device Name: GM85
• Manufacturer (Section D): SAMSUNG ELECTRONICS CO., LTD.; 129, samsung-ro, yeongtong-gu; suwon-si, gyeonggido 16677 ; KS 16677
• MDR Report Key: 23445316
• Report Number: 3004938766-2025-00027
• Device Sequence Number: 15693513
• Product Code: IZL
• UDI-Device Identifier: 08806088582412
• UDI-Public: 08806088582412
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/31/2025
• Report Date (Section F): 10/04/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/04/2025
• Event Location: Hospital
• Date Report to Manufacturer: 10/04/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/03/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown