MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-06-06 for 256 CHANNEL GES 400 CLINICAL EEG SYSTEM WITH IMAC manufactured by Electrical Geodesics, Inc..
[110709608]
The ges 400 system was being used in an emu room to record a patient's eeg. The ges 400 cart was positioned next to the patient 's bed with the camera parapet positioned above the patient. There were two emu staff near the cart, with the lead technician training a new technician. The technicians were adjusting the camera pole higher (pressed button to raise the pole) when they noticed that the camera pole became detached from the base as it was being raised. The lead technician asked the new technician to hold the pole to support the camera while she went to get the eeg department manager. When the manager came to the room, they assessed the situation and further movement caused the camera pole to mechanically detach from the cart as it was being held. The camera pole remained captive to the cart by way of the camera signal cable inside of the pole. The separation was controlled and no debris was released; there was no patient involvement. There was no allegation of patient or user injury. The eeg case was completed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3001090553-2018-00001 |
| MDR Report Key | 7574942 |
| Report Source | USER FACILITY |
| Date Received | 2018-06-06 |
| Date of Report | 2018-05-09 |
| Date of Event | 2018-05-09 |
| Date Mfgr Received | 2018-05-09 |
| Device Manufacturer Date | 2017-10-20 |
| Date Added to Maude | 2018-06-06 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. NANCY ANNUNZIATO |
| Manufacturer Street | 500 EAST 4TH AVENUE SUITE 200 |
| Manufacturer City | EUGENE OR 97401 |
| Manufacturer Country | US |
| Manufacturer Postal | 97401 |
| Manufacturer Phone | 5034076470 |
| 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 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 256 CHANNEL GES 400 CLINICAL EEG SYSTEM WITH IMAC |
| Generic Name | GES 400 |
| Product Code | GWQ |
| Date Received | 2018-06-06 |
| Returned To Mfg | 2018-05-22 |
| Lot Number | ZZ-01 3/29/16 8:29 |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2018-06-06 |