MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-17 for THYMATRON IV SYSTEM IV EDIV manufactured by Somatics, Llc.
[183741478]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9840653 |
| MDR Report Key | 9840653 |
| Date Received | 2020-03-17 |
| Date of Report | 2020-03-09 |
| Date of Event | 2020-02-26 |
| Report Date | 2020-03-09 |
| Date Reported to FDA | 2020-03-09 |
| Date Reported to Mfgr | 2020-03-17 |
| Date Added to Maude | 2020-03-17 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | THYMATRON IV |
| Generic Name | DEVICE, ELECTROCONVULSIVE THERAPY |
| Product Code | GXC |
| Date Received | 2020-03-17 |
| Model Number | SYSTEM IV |
| Catalog Number | EDIV |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SOMATICS, LLC |
| Manufacturer Address | 720 COMMERCE DRIVE, UNIT 101 VENICE FL 34292 US 34292 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-17 |