MAUDE Adverse Event Report: SAMSUNG ELECTRONICS CO., LTD. GU60A; DIGITAL RADIOGRAPHY GU60A

Model Number	GU60A
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Injury (2348)
Date of Event	01/03/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Service technician reviewed the system on site and found no malfunction.Each sensor was individually tested.Proximity sensor below the tube was also successfully verified.All control buttons responded in a normal manner.E-stop was also successfully tested.A similar exam was also done on the same anatomy of another subject that worked as prescribed.In conclusion, the system was not directly responsible for the injury and the patient reacted abruptly inducing his own injuries.System was fully verified to be in good working condition per manufacturing specifications by the field service engineer.
Event or Problem Description
A patient was positioned (supine) on the patient support awaiting the prescribed scan.As the x-ray tube was descending towards the patient to get into position (wherein the tube must be close to the patient), the patient moved out of the way and rolled himself off of the table.

• Brand Name: GU60A
• Common Device Name: DIGITAL RADIOGRAPHY GU60A
• Manufacturer (Section D): SAMSUNG ELECTRONICS CO., LTD.; 129, samsung-ro, yeongtong-gu; suwon-si, gyeonggi-do; 443-7 42; KS 443-742
• MDR Report Key: 6535319
• Report Number: 3004938766-2017-00004
• Device Sequence Number: 324050
• Product Code: KPR
• UDI-Device Identifier: 08806088566313
• UDI-Public: 08806088566313
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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): 04/26/2017
• Report Date (Section F): 05/01/2017

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: GU60A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/11/2017
• Device Age: 25 MO
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 04/26/2017
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/01/2017
• 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
• Patient Age: 67 YR
• Patient Weight: 141
• Date Report Sent to FDA: 05/01/2017