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

Model Number DGR1AEJNFCO24W

Device Problem Use of Device Problem (1670)

Patient Problem Abrasion (1689)

Event Date 05/15/2023

Event Type  Injury  

Manufacturer Narrative

The field service representative reviewed the computer log files for the system, and it was determined that the tech pressed a positioning button, which enabled the device to move in the manner it did.The positioning button allowed for the wall stand to come down onto the patient.This was concluded to be an unintended, user induced incident and not a product malfunction of the device.The patient was stated to be doing well and no other medical intervention was required.The site was referred to the user manual for proper handling of the device.No other information is available at this time.Any additional information received will be filed as a follow up mdr.

Event Description

The x-ray tech positioned the patient in front of the device to complete chest exam.The tech returned to the control area to make the first exposure when she heard the patient yelling.The wall stand had unintendedly come down on the patient's legs.The tech attended to the patient immediately and moved the stand away from the patient.The patient stated to be doing okay and the tech was able to complete the procedure.The patient indicated soreness and did not appear to have any serious injury.

• Brand Name: GM85
• Type of Device: 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: 17139015
• MDR Text Key: 317269179
• Report Number: 3004938766-2023-00012
• 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: 06/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: DGR1AEJNFCO24W
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Device Age: 4 YR
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 06/09/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1