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

Model Number	GM85
Medical Device Problem Codes	Labelling, Instructions for Use or Training Problem (1318); Human-Device Interface Problem (2949); Unintended Movement (3026)
Health Effect - Clinical Code	Crushing Injury (1797)
Date of Event	02/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is ongoing and not yet completed.The risk assessment will be reviewed during investigation.
Event or Problem 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
• Common Device Name: 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: 11639012
• Report Number: 3010300212-2021-00003
• Device Sequence Number: 19578753
• Product Code: IZL
• UDI-Device Identifier: 08806088582412
• UDI-Public: 08806088582412
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K182183
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/09/2021

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
• Operator of Device: No Information
• Device Model Number: GM85
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2021
• Initial Report FDA Received Date: 04/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1