MAUDE Adverse Event Report: SAMSUNG ELECTRONICS CO., LTD. GC80; THE GC80 DIGITAL X-RAY IMAGING SYSTEM

Model Number	GC80
Health Effect - Clinical Code	Injury (2348)
Date of Event	03/29/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product analysis showed that the device was working in accordance to specifications however, it looked that the operator was inadequately trained due to failure to obtain proper training.No impact on the user.A product incident report (b)(4) to assess the issue was initiated on april the 4th, 2018.
Event or Problem Description
During a gc80 scanning of the patient forearm, the technician was using the remote to lower the table onto the patient's legs.The patient got scared and pushed out from under the gc80's table scraping his legs.

• Brand Name: GC80
• Common Device Name: THE GC80 DIGITAL X-RAY IMAGING SYSTEM
• Manufacturer (Section D): SAMSUNG ELECTRONICS CO., LTD.; 129, samsung-ro, yeongtong-gu; suwon-si gyeonggi-do; 44374 2; KS 443742
• MDR Report Key: 7486576
• Report Number: 3004938766-2018-00001
• Device Sequence Number: 11250260
• Product Code: KPR
• UDI-Device Identifier: 08806086403467
• UDI-Public: 08806086403467
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Radiologic Technologist
• Type of Report: Initial
• Report Date (Section B): 05/04/2018
• Report Date (Section F): 05/04/2018

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: Radiologic Technologist
• Device Model Number: GC80
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/04/2018
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 05/05/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Date Report Sent to FDA: 05/04/2018