MAUDE Adverse Event Report: SAMSUNG ELECTRONICS CO., LTD. GC80; DIGITAL RADIOGRAPHY GC80

Model Number	GC80
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Injury (2348)
Date of Event	05/23/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
System was fully verified to be in good working condition per manufacturing specifications by a respective field service engineer.The injury was due to not following the correct protocols and the system was functioning properly.The field service rep was not able to duplicate this issue.Field service inspected the system on site - checked pui key, remote controller, stand side key and collimator key.Also examined the wall stand foot pedal and found no issues.
Event or Problem Description
During an l-spine ferguson at the wall stand, a seated exam, the tube head did not stop and hit the patient's knee.

• Brand Name: GC80
• Common Device Name: DIGITAL RADIOGRAPHY GC80
• Manufacturer (Section D): SAMSUNG ELECTRONICS CO., LTD.; 129, samsung-ro, yeongtong-gu; suwon-si, gyeonggi-do, ks 443-7 42; KS 443-742
• MDR Report Key: 6661103
• Report Number: 3004938766-2017-00007
• Device Sequence Number: 188282
• Product Code: KPR
• UDI-Device Identifier: 08806086403467
• UDI-Public: 08806086403467
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 06/22/2017
• Report Date (Section F): 06/22/2017

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: 05/23/2017
• Device Age: 2 YR
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 06/20/2017
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/22/2017
• 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: 06/22/2017