MAUDE Adverse Event Report: SAMSUNG ELECTRONICS CO., LTD GM60A; DIGITAL RADIOGRAPHY GM60A

Model Number	GM60A
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/06/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Service installed replacement stand alone board, tested system operation, no issues were found and unit charged and exposed as designed.The standalone pcb appeared to be the source of the burned smell that was noticed.The exact cause of this issue has not yet been determined, but it is under investigation.A pcb swap did solve the issue.Replacement pcb board was installed and system was fully verified to be in good working condition per manufacturing specifications by a respective field service engineer.No impact on patient outcome.No further action at this time, but will continue to support the customer as needed.
Event or Problem Description
Customer reported burning smell coming from the portable unit.Service arrived on site and inspected the power supply and found multiple burned components on the standalone pcb.

• Brand Name: GM60A
• Common Device Name: DIGITAL RADIOGRAPHY GM60A
• Manufacturer (Section D): SAMSUNG ELECTRONICS CO., LTD; 129, samsung-ro, yeongtong-gu; suwon-si, gyeonggi-do, ks 44374 2; KS 443742
• MDR Report Key: 6926643
• Report Number: 3004938766-2017-00011
• Device Sequence Number: 1142319
• Product Code: KPR
• UDI-Device Identifier: 08806088566313
• UDI-Public: 08806088566313
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Radiologic Technologist
• Type of Report: Initial
• Report Date (Section B): 10/06/2017
• Report Date (Section F): 10/07/2017

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: Radiologic Technologist
• Device Model Number: GM60A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 07/06/2017
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Date Report Sent to FDA: 10/07/2017