MAUDE Adverse Event Report: SAMSUNG ELECTRONICS CO., LTD. GM85; COMMON DEVICE NAME DIGITIAL DIAGNOSTIC X-RAY SYSTEM

Model Number DGR2ABA1BDNNYW

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Insufficient Information (4580)

Event Date 05/15/2023

Event Type  Death  

Manufacturer Narrative

The incident occurred on (b)(6) 2023, and neurologica was informed on june 7, 2023.Neurologica immediatley dispatched field service engineers to the site to assess the system.After conversations with staff members and assessment of the device, it was determined that the image rotation was completed by the customer.The system was thoroughly reviewed and no issues were found with the system.Any additional information will be filed under a follow-up mdr.

Event Description

Customer called and informed call center that while using the device, the image used to perform a surgery was rotated.The surgeon operated on the patient with misinformation.

• Brand Name: GM85
• Type of Device: COMMON DEVICE NAME DIGITIAL DIAGNOSTIC X-RAY SYSTEM
• Manufacturer (Section D): SAMSUNG ELECTRONICS CO., LTD.; 129, samsung-ro; yeongtong-gu; suwon-si, gyeonggi-do 16677 ; KS 16677
• MDR Report Key: 17244413
• MDR Text Key: 318262048
• Report Number: 3004938766-2023-00013
• Device Sequence Number: 1
• Product Code: IZL
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 06/30/2023

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
• Device Operator: Health Professional
• Device Model Number: DGR2ABA1BDNNYW
• 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: 06/30/2023
• Distributor Facility Aware Date: 06/07/2023
• Device Age: 3 YR
• Date Report to Manufacturer: 06/15/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/02/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death