MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2015-03-18 for ZYNEX NEXWAVE manufactured by Zynex Medical, Inc..
[17998547]
Unit got hot and started to smell like sulpher and burning smell. Then the unit shut off and doesn't turn on at all.
Patient Sequence No: 1, Text Type: D, B5
[18393998]
Zynex: no unusual indications from exterior inspection. Internal inspection reveals that f1 shows signs of discoloration. F1, q27 and q28 bad. Any components that aren't functioning properly would give off a burning smell. Complaint confirmed. No harm to patient.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1723686-2015-00014 |
| MDR Report Key | 4617676 |
| Report Source | 99 |
| Date Received | 2015-03-18 |
| Date of Report | 2015-03-13 |
| Date of Event | 2013-10-24 |
| Date Mfgr Received | 2013-11-08 |
| Device Manufacturer Date | 2012-01-01 |
| Date Added to Maude | 2015-05-01 |
| 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 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ZYNEX |
| Generic Name | ELECTRICAL STIMULATOR |
| Product Code | IPF |
| Date Received | 2015-03-18 |
| Returned To Mfg | 2013-11-08 |
| 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 80120 US 80120 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-03-18 |