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

Model Number	GM85
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/23/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon inspection, it was found that the resistor for the motor driver on the right swing out door had a wire that melted to a bolt.The system has undergone repairs to the necessary components.No injury to the operator or patients.Future service calls will be monitored for similar issues.
Event or Problem Description
The customer was using the system in the emergency department.While the device was not being driven, but on battery power, smoke appeared on the right side.The site called the fire department and the system was moved to a safe area.

• Brand Name: GM85
• Common Device Name: DIGITAL DIAGNOSTIC X-RAY SYSTEM, PRODUCT CODE
• Manufacturer (Section D): SAMSUNG ELECTRONICS CO., LTD.; 129, samsung-ro,; yeongtong-gu; suwon-si, gyeonggido 16677 ; KS 16677
• MDR Report Key: 11152962
• Report Number: 3010300212-2021-00001
• Device Sequence Number: 4116863
• Product Code: IZL
• UDI-Device Identifier: 08806088582412
• UDI-Public: 08806088582412
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 01/11/2021

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: No Information
• Device Model Number: GM85
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2020
• Initial Report FDA Received Date: 01/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1