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

Model Number	GM85
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Superficial (First Degree) Burn (2685)
Date of Event	12/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The field service rep completed inspection of system and found the power cord end was burned.The field service rep completed necessary testing and determined that the power cord and plug of the unit wss not a good condition.The necessary components were replaced and the unit operates as intended without any further issues.No further corrective measures necessary.This is the first event received from field due to power cord burn issue.Future service calls will be monitored for similar issues and escalated if necessary.
Event or Problem Description
Technician burned his finger when they touched the power cord.It was noted that the tech's finger was a little red but they did not need medical attention.

• 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: 11283801
• Report Number: 3010300212-2021-00002
• Device Sequence Number: 14500264
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: GM85
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2021
• Initial Report FDA Received Date: 02/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1