MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-11 for ELITE AUTO SHUT-OFF 200R MAIN XMD008 manufactured by Natus Neurology Incorporated.
| Report Number | 3010611950-2020-00003 |
| MDR Report Key | 9819492 |
| Date Received | 2020-03-11 |
| Date of Report | 2020-03-11 |
| Date Mfgr Received | 2020-02-12 |
| Date Added to Maude | 2020-03-11 |
| 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 CLAIRE KENNEDY |
| Manufacturer Street | 3150 PLEASANT VIEW ROAD MIDDLETON, WISCONSIN 53562 US |
| Manufacturer Country | US |
| Manufacturer G1 | NATUS MANUFACTURING LTD |
| Manufacturer Street | IDA BUSINESS PARK GORT |
| Manufacturer City | CO. GALWAY, |
| Manufacturer Country | EI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ELITE AUTO SHUT-OFF 200R MAIN |
| Generic Name | ELITE AUTO SHUT-OFF 200R MAIN |
| Product Code | JAF |
| Date Received | 2020-03-11 |
| Model Number | XMD008 |
| Catalog Number | XMD008 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | N |
| 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 | 1. Other | 2020-03-11 |