MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-08-24 for NIM? 2.0 MAINFRAME 8252001 manufactured by Medtronic Xomed Inc..
[24553312]
Blank fields in this report are the result of information not provided by the initial reporter or user facility. This device is used for therapeutic purposes. (b)(4). The device was returned for evaluation and repair at the (b)(4) depot in (b)(4). There was no fault found with the device; therefore, the most likely root cause is related to operational context or user error. The device was cleaned, tested to product specifications and returned to the customer.
Patient Sequence No: 1, Text Type: N, H10
[24553313]
It was reported that during set-up [testing] the mainframe will not stimulate. There was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5
[33752481]
Additional information obtained established the user did not experience a visual waveform and there was no tone; although they did visualize confirmation that the electrodes were recognized on the monitoring screen during setup.
Patient Sequence No: 1, Text Type: N, H10
[33752482]
Additional information obtained established the user did not experience a visual waveform and there was no tone; although they did visualize confirmation that the electrodes were recognized on the monitoring screen during setup.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1045254-2015-00284 |
| MDR Report Key | 5024883 |
| Date Received | 2015-08-24 |
| Date of Report | 2015-08-25 |
| Date of Event | 2015-07-29 |
| Date Mfgr Received | 2015-08-25 |
| Device Manufacturer Date | 2008-06-05 |
| Date Added to Maude | 2015-08-24 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | CHARLOTTE AYALA |
| Manufacturer Street | 6743 SOUTHPOINT DR N |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal | 32216 |
| Manufacturer Phone | 9043328372 |
| Manufacturer G1 | MEDTRONIC |
| 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? 2.0 MAINFRAME |
| Generic Name | ELECTROMYOGRAPH, DIAGNOSTIC |
| Product Code | IKN |
| Date Received | 2015-08-24 |
| Returned To Mfg | 2015-07-30 |
| Model Number | 8252001 |
| Catalog Number | 8252001 |
| Lot Number | 56342800 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| 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 | 2015-08-24 |