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

Model Number GM85

Device Problems Labelling, Instructions for Use or Training Problem (1318); Human-Device Interface Problem (2949); Unintended Movement (3026)

Patient Problem Crushing Injury (1797)

Event Date 02/26/2021

Event Type  Injury  

Manufacturer Narrative

A field service representative visited the site and noted that the device was driving adequately.It was determined that if the system was not fully locked into place, the arm could slide when the user moved the device.This issue was a user induced incident.The injured technician did receive medical attention, however, it was confirmed there were no breaks or sprains to their finger.No further corrective measures necessary.Future service calls will be monitored for similar issues and escalated if necessary.

Event Description

While driving the device, the system arm moved unintentionally, causing the user's finger to get pinched/crushed by the device.

• Brand Name: GM85
• 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
• MDR Report Key: 11579645
• MDR Text Key: 246217935
• Report Number: 3004938766-2021-00003
• 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: 03/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: GM85
• 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: 03/26/2021
• Distributor Facility Aware Date: 03/05/2021
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 03/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1