MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-02-27 for NIM? 3.0 MAINFRAME 8253001 manufactured by Medtronic Xomed Inc..
[182005354]
Mainframe: analysis found it could not verify customers issue regarding not working properly. No fault found with the unit. The item was tested and passed all manufacturing specifications. Patient interface: analysis found it could not verify customers issue. Replaced wave washer due to loose cable cup and replaced missing spare fuse and o-ring the was tested and passed all manufacturing specifications. Other relevant device(s) are: product id: 8253200, serial/lot #: (b)(4), udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[182005355]
A healthcare provider (hcp) reported that a nerve monitoring device mainframe, patient interface were not working properly mentioned by the surgeon but according to biomed and rep they work fine. There was no patient impact.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1045254-2020-00110 |
| MDR Report Key | 9763390 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-02-27 |
| Date of Report | 2020-02-27 |
| Date of Event | 2020-02-03 |
| Date Mfgr Received | 2020-02-03 |
| Device Manufacturer Date | 2012-05-24 |
| Date Added to Maude | 2020-02-27 |
| 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 | CHRISTY CAIN |
| Manufacturer Street | 6743 SOUTHPOINT DRIVE NORTH |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal | 32216 |
| Manufacturer Phone | 9043328353 |
| Manufacturer G1 | MEDTRONIC XOMED INC. |
| Manufacturer Street | 6743 SOUTHPOINT DR N |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 32216 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NIM? 3.0 MAINFRAME |
| Generic Name | STIMULATOR, NERVE |
| Product Code | ETN |
| Date Received | 2020-02-27 |
| Returned To Mfg | 2020-02-12 |
| Model Number | 8253001 |
| Catalog Number | 8253001 |
| Lot Number | 205915527 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC XOMED INC. |
| Manufacturer Address | 6743 SOUTHPOINT DR N JACKSONVILLE FL 32216 US 32216 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-27 |