MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-09-19 for S4500 BEDSIDE UNIT 2000204 manufactured by Embla Systems.
| Report Number | 3005888786-2019-00001 |
| MDR Report Key | 9087588 |
| Date Received | 2019-09-19 |
| Date of Report | 2019-04-16 |
| Date of Event | 2019-04-02 |
| Date Mfgr Received | 2019-04-16 |
| Date Added to Maude | 2019-09-19 |
| 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 | MR. SANJAY MEHTA |
| Manufacturer Street | 2568 BRISTOL CIRCLE |
| Manufacturer City | OAKVILLE, ONTARIO L6H 5S1 |
| Manufacturer Country | CA |
| Manufacturer Postal | L6H 5S1 |
| Manufacturer G1 | EMBLA SYSTEMS |
| Manufacturer Street | 1 HINES ROAD |
| Manufacturer City | KANATA, K2K 3C7 |
| Manufacturer Country | CA |
| Manufacturer Postal Code | K2K 3C7 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | S4500 BEDSIDE UNIT |
| Generic Name | ELECTROENCEPHALOGRAPH |
| Product Code | MNR |
| Date Received | 2019-09-19 |
| Model Number | 2000204 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EMBLA SYSTEMS |
| Manufacturer Address | 1 HINES ROAD SUITE 202 KANATA, K2K 3C7 CA K2K 3C7 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-09-19 |