MAUDE Adverse Event Report: SAMSUNG ELECTRONICS CO., LTD. DIGITAL RADIOGRAPHY; GC85A

Model Number GC85A

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Injury (2348)

Event Date 04/27/2017

Event Type  Injury  

Manufacturer Narrative

System was fully verified to be in good working condition per manufacturing specifications (as noted) by the respective field service engineer.Field service inspected the system on site and found no malfunction of the system.We were able to confirm that this happened as the wrong button (bucky tracking) was pressed at the wrong time causing injury to the toes on both feet of the patient.The injury was caused by operator error.The operator was new to the gc85a system & was unfamiliar with all of it's features.The customer will add a barrier at end of weight bearing stand to keep patient toes from "hanging" over the edge of weight bearing stand.Educateing technologists on how the tracking system works to avoid such incidents in the future.

Event Description

The technologist was doing a standing knee view in front of the wall stand.The patient was standing on a weight bearing stand.The technologist turned the auto tracking off on the tube head unit (thu) to bring the tube head lower than the wall bucky to use the detector wirelessly.The technologist accidently hit the tracking button & turned auto tracking back on, which caused the wall stand to lower itself to align automatically to the tube (which is what it is supposed to do) but unfortunately caused injury to the patient's toes.

• Brand Name: DIGITAL RADIOGRAPHY
• Type of Device: GC85A
• 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: 6616173
• MDR Text Key: 76822563
• Report Number: 3004938766-2017-00005
• Device Sequence Number: 1
• Product Code: KPR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/26/2017,05/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Radiologic Technologist
• Device Model Number: GC85A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/26/2017
• Device Age: 3 MO
• Event Location: Hospital
• Date Report to Manufacturer: 05/26/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other