MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-27 for ELITE X1L001 manufactured by Natus Neurology Incorporated.
| Report Number | 3010611950-2020-00009 |
| MDR Report Key | 9892041 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-27 |
| Date Added to Maude | 2020-03-27 |
| 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 | CLAIRE KENNEDY |
| Manufacturer Street | IDA BUSINESS PARK GORT, H91PD9 CO. GALWAY |
| Manufacturer Country | EI |
| Manufacturer G1 | NATUS NEUROLOGY INCORPORATED |
| Manufacturer Street | 3150 PLEASANT VIEW ROAD MIDDLETON WISCONSIN |
| Manufacturer City | 53562, USA, |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ELITE |
| Generic Name | ELITE |
| Product Code | IYN |
| Date Received | 2020-03-27 |
| Model Number | X1L001 |
| Catalog Number | X1L001 |
| Lot Number | ECU0100 / CAT1567 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NATUS NEUROLOGY INCORPORATED |
| Manufacturer Address | 3150 PLEASANT VIEW ROAD MIDDLETON, WISCONSIN 53562, USA, US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-27 |