MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2019-10-15 for GES 400 manufactured by Electrical Geodesics, Inc..
| Report Number | 3001090553-2019-00001 |
| MDR Report Key | 9195123 |
| Report Source | USER FACILITY |
| Date Received | 2019-10-15 |
| Date of Report | 2019-10-15 |
| Date of Event | 2019-09-16 |
| Date Mfgr Received | 2019-09-16 |
| Device Manufacturer Date | 2017-05-30 |
| Date Added to Maude | 2019-10-15 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. MARCUS PALMER |
| Manufacturer Street | 500 EAST 4TH AVENUE SUITE 200 |
| Manufacturer City | EUGENE OR 97401 |
| Manufacturer Country | US |
| Manufacturer Postal | 97401 |
| Manufacturer Phone | 5412060838 |
| Manufacturer G1 | ELECTRICAL GEODESICS, INC. |
| Manufacturer Street | 500 EAST 4TH AVENUE SUITE 200 |
| Manufacturer City | EUGENE OR 97401 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 97401 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GES 400 |
| Generic Name | 256 CHANNEL GES400 CLINICAL EEG SYSTEM W/IMAC |
| Product Code | GWQ |
| Date Received | 2019-10-15 |
| Lot Number | ZZ-01 03/29/16 8:29 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ELECTRICAL GEODESICS, INC. |
| Manufacturer Address | 500 EAST 4TH AVENUE SUITE 200 EUGENE OR 97401 US 97401 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-10-15 |