MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2020-02-28 for NEUROSIGN 4230-00 manufactured by The Magstim Company Ltd..
[187906113]
Another visit to the customer was planned to further investigate. The magstim company ltd. Is, as per your request, currently in the process of setting up a webtrader account for magstim inc. Usa. During this transition time, please accept this submission as of the magstim company ltd. And magstim inc. Usa both. Exemption number e2018009. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[187906114]
It was reported that the machine was producing a disturbing sound during use, even after checking the impedance. The customer advised that last time it was used for a thyroidectomy surgery, when the bipolar stimulating probe was connected, it did not work (no signal or any function from device). After the probe was removed, the device did not work anymore. The surgery was further performed without monitoring. No reports of patient/user or any person harm was received.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011755356-2020-00003 |
| MDR Report Key | 9768114 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-02-28 |
| Date of Report | 2020-01-06 |
| Date Mfgr Received | 2020-01-06 |
| Date Added to Maude | 2020-02-28 |
| 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 | MISS INEKE BOEK |
| Manufacturer Street | SPRING GARDENS |
| Manufacturer City | WHITLAND, CARMARTHENSHIRE SA340HR |
| Manufacturer Country | UK |
| Manufacturer Postal | SA34 0HR |
| Manufacturer G1 | THE MAGSTIM COMPANY LTD. |
| Manufacturer Street | SPRING GARDENS |
| Manufacturer City | WHITLAND, CARMARTHENSHIRE SA340HR |
| Manufacturer Country | UK |
| Manufacturer Postal Code | SA34 0HR |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NEUROSIGN |
| Generic Name | NEUROSIGN V4 |
| Product Code | ETN |
| Date Received | 2020-02-28 |
| Catalog Number | 4230-00 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | THE MAGSTIM COMPANY LTD. |
| Manufacturer Address | SPRING GARDENS WHITLAND, CARMARTHENSHIRE SA340HR UK SA34 0HR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-02-28 |