MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-01-21 for VIKINGQUEST 982A0474 manufactured by Natus Neurology, Incorporated.
[36525374]
Registered internally as a complaint ((b)(4)) for further investigation by manufacturer. The attending physician indicated medical intervention was not needed during or after the surgical procedure to treat the affected burn area. The device history record was reviewed as compiled when the emg system in question was manufactured. The equipment met all required specifications at the time of manufacture. Device evaluated by manufacturer: the vikingquest system associated with this mdr was evaluated onsite by a trained natus field engineer on january 5, 2016. The field engineer reported there were no visual, electrical or functional defects found with the emg system identified. 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. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[36525375]
A customer in (b)(6) reported a patient may have received electrode burns to the hand/forearm during a surgical procedure when the natus equipment indicated (vikingquest emg system, sn (b)(4)) was in use. Other surgical equipment (not natus equipment) including electro-cautery equipment was also in use.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010611950-2016-00001 |
| MDR Report Key | 5383230 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-01-21 |
| Date of Report | 2016-01-05 |
| Date of Event | 2015-12-28 |
| Date Mfgr Received | 2015-12-29 |
| Device Manufacturer Date | 2013-11-11 |
| Date Added to Maude | 2016-01-21 |
| 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 | 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 | VIKINGQUEST |
| Generic Name | ELECTROMYGRAPH |
| Product Code | IKN |
| Date Received | 2016-01-21 |
| Model Number | 982A0474 |
| Catalog Number | 982A0474 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NATUS NEUROLOGY, INCORPORATED |
| Manufacturer Address | 3150 PLEASANT VIEW ROAD MIDDLETON WI 53562 US 53562 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-01-21 |