MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2015-03-13 for ZYNEX NEXWAVE manufactured by Zynex Medical, Inc..
[5702202]
Channel 1 error occurs 10-15 minutes into treatment/burned plastic smell. Had pt test lw switched lw then run unit again. Channel 1 error occurred after lw were switched. Pt indicates that she can smell burned plastic. No harm to pt.
Patient Sequence No: 1, Text Type: D, B5
[13031785]
Zynex: unit was tested with no problem found and passed the final test. Tested for duration with no burned plastic smell or errors of any kind. There is no evidence internally or externally suggesting unit ever got hot or had any burning plastic smell.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1723686-2015-00010 |
| MDR Report Key | 4613354 |
| Report Source | 99 |
| Date Received | 2015-03-13 |
| Date of Report | 2015-03-11 |
| Date of Event | 2013-11-04 |
| Date Mfgr Received | 2013-11-13 |
| Device Manufacturer Date | 2013-11-13 |
| Date Added to Maude | 2015-04-27 |
| 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 Street | 9990 PARK MEADOWS DRIVE |
| Manufacturer City | LONE TREE CO 80124 |
| Manufacturer Country | US |
| Manufacturer Postal | 80124 |
| Manufacturer Phone | 3037034906 |
| Single Use | 0 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ZYNEX |
| Generic Name | ELECTRICAL STIMULATOR |
| Product Code | IPF |
| Date Received | 2015-03-13 |
| Returned To Mfg | 2013-11-13 |
| Model Number | NEXWAVE |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZYNEX MEDICAL, INC. |
| Manufacturer Address | LONE TREE CO 80124 US 80124 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-03-13 |