MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-02-22 for NATUS VIKING SELECT 982A0403 manufactured by Natus Neurology, Incorportaed.
[38744004]
Registered internally as a complaint (reference (b)(4)) for further investigation by manufacturer. One day after the incident was reported, the equipment indicated was evaluated on site by a trained natus field service technician, tested, and found to be operating within specification. Electro-cautery equipment was in use by the complainant at the same time as the natus device in question. There are known risks associated with such device to device combinations where electrodes can intercept stray radio frequency energy and result in thermal heating. Natus safety information supplied to end users states such interactions exist and warns end users that electrode disconnection may be needed to avoid such interactions (ref natus safety reference guide, label # (b)(4)). A separate mdr is being filed for the electrodes in use at the time of the incident (ref mdr 3010611950-2016-00003).
Patient Sequence No: 1, Text Type: N, H10
[38744005]
Customer reported a patient received an electrode burn while using a natus viking select oem system, pn 982a0403, sn (b)(4). Customer also reported that electro-cautery equipment (not a natus device) was in use at the same time the viking select system was in use.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010611950-2016-00002 |
| MDR Report Key | 5452447 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-02-22 |
| Date of Report | 2016-02-02 |
| Date of Event | 2016-02-01 |
| Date Mfgr Received | 2016-02-02 |
| Device Manufacturer Date | 2011-03-09 |
| Date Added to Maude | 2016-02-22 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. RANDALL MOOG |
| Manufacturer Street | 3150 PLEASANT VIEW ROAD |
| Manufacturer City | MIDDLETON WI 53562 |
| Manufacturer Country | US |
| Manufacturer Postal | 53562 |
| Manufacturer Phone | 6088298802 |
| 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 | NATUS VIKING SELECT |
| Generic Name | ELECTROMYGRAPH |
| Product Code | IKN |
| Date Received | 2016-02-22 |
| Model Number | 982A0403 |
| Catalog Number | 982A0403 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NATUS NEUROLOGY, INCORPORTAED |
| Manufacturer Address | 3150 PLEASANT VIEW ROAD MIDDLETON WI 53562 US 53562 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-02-22 |