MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-05-27 for NICOLET EDX VIKING * manufactured by Natus Neurology, Incorporated.
[5919291]
Patient was undergoing a single fiber stimulated emg of the left frontalis muscle. The stimulation of the emg was administered using two sub-dermal needle electrodes. Upon removal of the sub-dermal electrodes two burns were noted at the electrode placement sites. The patient was sent to the emergency center for evaluation and it was determined that the patient had third degree burns. The machine was sequestered and evaluated by the manufacturer. ======================manufacturer response for electromyography machine, viking edx (per site reporter). ======================spoke with field/repair engineers. They were to conduct an investigation. The results of this investigation have not yet been communicated to anyone at the hospital. I tried several times to contact an engineer at the manufacturer and have not been able to get a response.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 4817635 |
| MDR Report Key | 4817635 |
| Date Received | 2015-05-27 |
| Date of Report | 2015-05-27 |
| Date of Event | 2015-05-13 |
| Report Date | 2015-05-27 |
| Date Reported to FDA | 2015-05-27 |
| Date Reported to Mfgr | 2015-06-04 |
| Date Added to Maude | 2015-06-04 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NICOLET EDX |
| Generic Name | ELECTROMYOGRAPH, DIAGNOSTIC |
| Product Code | IKN |
| Date Received | 2015-05-27 |
| Returned To Mfg | 2015-05-15 |
| Model Number | VIKING |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | 1 YR |
| 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; 2. Required No Informationntervention | 2015-05-27 |