MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2015-07-30 for VIKING SELECT 982A0403 manufactured by Natus Neurology, Incorportaed.
[6194748]
Patient was burned during spinal fusion surgery at the site of emg stimulating electrodes (one burn on left elbow (~4mm x 3mm) and two burns on left ankle (one a pinpoint, the second ~ 5mm x 7mm)). Procedure was 6 -- 7 hours. Customer was also using an electro-cautery instrument (not a natus device).
Patient Sequence No: 1, Text Type: D, B5
[13967028]
1) registered internally as a complaint (reference (b)(4)) for further investigation by manufacturer. 2) the equipment was evaluated at the complainants location by a trained natus field service technician and found to be operating acceptably. Components related to electrode connection and stimulating functions were returned to the manufacturer for further evaluation. Testing included electrical and stimulus function testing. That evaluation concluded that those components were found to be operating normally and there were no indications that a malfunction of those components had contributed to the burns at the electrode sites. 3) the electrodes used in conjunction with this equipment were reported under a seperate mdr (reference 3010611950-2015-00006). 4) 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)).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3010611950-2015-00004 |
| MDR Report Key | 4954578 |
| Report Source | 05 |
| Date Received | 2015-07-30 |
| Date of Report | 2015-07-08 |
| Date of Event | 2015-07-06 |
| Date Mfgr Received | 2015-07-08 |
| Device Manufacturer Date | 2011-03-10 |
| Date Added to Maude | 2015-07-31 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | 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 | VIKING SELECT |
| Generic Name | ELECTROMYGRAPH |
| Product Code | IKN |
| Date Received | 2015-07-30 |
| Returned To Mfg | 2015-07-20 |
| Model Number | 982A0403 |
| Catalog Number | 982A0403 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2015-07-30 |