MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-05-23 for NATUS EMU40EX 006562 manufactured by Natus Medical Inc. Dba Excel-tech Ltd ((xltek).
[75732749]
Patient Sequence No: 1, Text Type: N, H10
[75732750]
The break out box on the xltek emu40ex is mislabeled. Color coding to indicate right/left side was reversed. No known patient harm occurred with use of the equipment. Manufacturer response for eeg electrodes, (brand not provided) (per site reporter): manufacturer sent replacement..
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6584029 |
| MDR Report Key | 6584029 |
| Date Received | 2017-05-23 |
| Date of Report | 2017-05-18 |
| Date of Event | 2017-01-31 |
| Report Date | 2017-02-17 |
| Date Reported to FDA | 2017-02-17 |
| Date Reported to Mfgr | 2017-02-17 |
| Date Added to Maude | 2017-05-23 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NATUS EMU40EX |
| Generic Name | ELECTROENCEPHALOGRAPH |
| Product Code | GWQ |
| Date Received | 2017-05-23 |
| Model Number | 006562 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NATUS MEDICAL INC. DBA EXCEL-TECH LTD ((XLTEK) |
| Manufacturer Address | 1501 INDUSTRIAL ROAD SAN CARLOS CA 94070 US 94070 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-05-23 |