MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-03-07 for NICOLETONE EEG V32 AMPLIFIER 515-019000F N/A manufactured by Natus Neurology Incorporated.
[101981725]
(b)(4). The system was removed from service and the amplifier was returned to natus for evaluation. The evaluation found no problems with the amplifier. A natus field service technician is going on site to evaluate the system.
Patient Sequence No: 1, Text Type: N, H10
[101981726]
Eeg brain test; waves appeared flat, in reality they were not flat.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010611950-2018-00001 |
| MDR Report Key | 7322136 |
| Report Source | USER FACILITY |
| Date Received | 2018-03-07 |
| Date of Report | 2018-01-17 |
| Date of Event | 2018-01-17 |
| Date Mfgr Received | 2018-01-17 |
| Device Manufacturer Date | 2015-05-22 |
| Date Added to Maude | 2018-03-07 |
| 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 | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. JANESSA BOONE |
| Manufacturer Street | 3150 PLEASANT VIEW ROAD |
| Manufacturer City | MIDDLETON WI 53562 |
| Manufacturer Country | US |
| Manufacturer Postal | 53562 |
| Manufacturer Phone | 6088298603 |
| Manufacturer G1 | NATUS NEUROLOGY INCORPORATED |
| Manufacturer Street | 3150 PLEASANT VIEW ROAD |
| Manufacturer City | MIDDLETON WI 53562 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 53562 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NICOLETONE EEG V32 AMPLIFIER |
| Generic Name | NICOLETONE |
| Product Code | GWQ |
| Date Received | 2018-03-07 |
| Model Number | 515-019000F |
| Catalog Number | N/A |
| Lot Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NATUS NEUROLOGY INCORPORATED |
| Manufacturer Address | 3150 PLEASANT VIEW ROAD MIDDLETON WI 53562 US 53562 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-03-07 |