MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2015-03-13 for ZYNEX NEXWAVE manufactured by Zynex Medical, Inc..
[18002712]
Device is shocking patient even with new pads and lead wires.
Patient Sequence No: 1, Text Type: D, B5
[18135359]
Zynex: patient did not return ac adapter or lead wires. Unit turned on, passed final testing without any problems. No problem found.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1723686-2015-00009 |
| MDR Report Key | 4613398 |
| Report Source | 04 |
| Date Received | 2015-03-13 |
| Date of Report | 2015-03-11 |
| Date of Event | 2014-08-04 |
| Date Mfgr Received | 2015-01-20 |
| Device Manufacturer Date | 2011-12-13 |
| 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 | 3 |
| 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 | 2015-01-20 |
| Model Number | NEXWAVE |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| 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 |