MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2017-06-21 for ELITE PROBE X1L001 N300 manufactured by Natus Neurology, Incorporated.
[78054349]
(b)(4). Based on risk assessment conducted may 25, 2017, it was determined that there is a risk of injury if the malfunction were to recur. There have been no reported injuries. Reference field corrective action number: 3010611950/06/09/2017/001-r.
Patient Sequence No: 1, Text Type: N, H10
[78054350]
Excessive static noise observed in elite probe.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010611950-2017-00022 |
| MDR Report Key | 6656750 |
| Report Source | DISTRIBUTOR |
| Date Received | 2017-06-21 |
| Date of Report | 2017-05-02 |
| Date of Event | 2017-05-02 |
| Date Mfgr Received | 2017-05-02 |
| Device Manufacturer Date | 2017-03-29 |
| Date Added to Maude | 2017-06-21 |
| 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. 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 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ELITE PROBE |
| Generic Name | ELITE 3MHZ PROBE |
| Product Code | JAF |
| Date Received | 2017-06-21 |
| Returned To Mfg | 2017-05-12 |
| Model Number | X1L001 |
| Catalog Number | N300 |
| Lot Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2017-06-21 |