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

Model Number GC80

Device Problems Computer Software Problem (1112); Display or Visual Feedback Problem (1184)

Patient Problem Unintended Radiation Exposure (4565)

Event Date 10/19/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing and not yet completed. The risk assessment will be reviewed during investigation.

Event Description

The customer reported that they could not obtain all required images, and they had to re-expose a (b)(6) patient.

• Brand Name: GC80
• Type of Device: DIGITAL DIAGNOSTIC X-RAY SYSTEM
• Manufacturer (Section D): SAMSUNG ELECTRONICS CO., LTD.; 129, samsung-ro, yeongtong-gu; suwon-si, gyeonggido 16677 ; KS 16677
• Manufacturer (Section G): SAMSUNG ELECTRONICS CO., LTD.; 129, samsung-ro yeongtong-gu; suwon-si, gyeonggido 16677 ; KS 16677
• Manufacturer Contact: jeongwoo kim ; 129, samsung-ro yeongtong-gu; suwon-si, gyeonggido 16677 ; KS 16677
• MDR Report Key: 12850267
• MDR Text Key: 281104901
• Report Number: 3010300212-2021-00007
• Device Sequence Number: 1
• Product Code: KPR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/22/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 11/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: GC80
• Device Catalogue Number: 515CM3HJ100001L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/23/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/19/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No