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

Model Number SYSTEM IV

Device Problems Smoking (1585); Sparking (2595); Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/26/2020

Event Type  No Answer Provided  

Event 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
• Type of Device: DEVICE, ELECTROCONVULSIVE THERAPY
• Manufacturer (Section D): SOMATICS, LLC; 720 commerce drive, unit 101; venice FL 34292
• MDR Report Key: 9840653
• MDR Text Key: 183741478
• Report Number: 9840653
• Device Sequence Number: 1
• Product Code: GXC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

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