MAUDE Adverse Event Report: SOMATICS, LLC THYMATRON IV; DEVICE, ELECTROCONVULSIVE THERAPY

Model Number	SYSTEM IV
Medical Device Problem Codes	Smoking (1585); Sparking (2595); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/26/2020
Event or Problem Description
Pt here for electro-convulsive therapy treatment.When electro shock given, a spark and smoke arose from electropad on r temple of pt.Electro pad actually popped off on skin leaving a small black mark.Black mark wiped off when skin cleansed for examination and no obvious burn mark was noted.Electro-convulsive therapy device removed from service pending biomed review.

• Brand Name: THYMATRON IV
• Common Device Name: DEVICE, ELECTROCONVULSIVE THERAPY
• Manufacturer (Section D): SOMATICS, LLC; 720 commerce drive, unit 101; venice FL 34292
• MDR Report Key: 9840653
• Report Number: 9840653
• Device Sequence Number: 13209986
• Product Code: GXC
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 03/09/2020
• Report Date (Section F): 03/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Operator of Device: No Information
• Device Model Number: SYSTEM IV
• Device Catalogue Number: EDIV
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/17/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/17/2020
• Patient Sequence Number: 1
• Date Report Sent to FDA: 03/09/2020