MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-20 for XLTEK EEG/PSG DELL OPTIPLEX 5050 SMALL FORM FACTOR SYSTEM 023087 manufactured by Natus Medical Incorporated Dba Excel-tech Ltd. (xl.
| Report Number | 9612330-2020-00005 |
| MDR Report Key | 9862956 |
| Date Received | 2020-03-20 |
| Date of Report | 2020-03-20 |
| Date Added to Maude | 2020-03-20 |
| 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 | IDA BUSINESS PARK GORT, CO. GALWAY |
| Manufacturer City | GALWAY, |
| Manufacturer Country | EI |
| Manufacturer G1 | NATUS MEDICAL INCORPORATED DBA EXCEL-TECH LTD. (XL |
| Manufacturer Street | 2568 BRISTOL CIRCLE OAKVILLE, ONTARIO, |
| Manufacturer City | L6H 5S1 CANADA, |
| Manufacturer Country | CA |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | XLTEK EEG/PSG DELL OPTIPLEX 5050 SMALL FORM FACTOR SYSTEM |
| Generic Name | XLTEK EEG/PSG DELL OPTIPLEX 5050 SMALL FORM FACTOR SYSTEM |
| Product Code | FTT |
| Date Received | 2020-03-20 |
| Model Number | 023087 |
| Catalog Number | 023087 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NATUS MEDICAL INCORPORATED DBA EXCEL-TECH LTD. (XL |
| Manufacturer Address | 2568 BRISTOL CIRCLE OAKVILLE, ONTARIO, L6H 5S1 CANADA, CA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-20 |