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

Model Number GC80

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Injury (2348)

Event Date 05/23/2017

Event Type  Injury  

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 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
• Type of Device: 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
• MDR Text Key: 78183813
• Report Number: 3004938766-2017-00007
• Device Sequence Number: 1
• Product Code: KPR
• UDI-Device Identifier: 08806086403467
• UDI-Public: 08806086403467
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 06/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Radiologic Technologist
• Device Model Number: GC80
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/22/2017
• Distributor Facility Aware Date: 05/23/2017
• Device Age: 2 YR
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 06/20/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other