MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2014-08-05 for ZYNEX manufactured by Zynex Medical.
[5314266]
The unit was smoking.
Patient Sequence No: 1, Text Type: D, B5
[12862992]
Conclusion: the q26, 27, 28, 29 components were the cause of the failure.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1723686-2014-00005 |
| MDR Report Key | 4445134 |
| Report Source | 99 |
| Date Received | 2014-08-05 |
| Date of Report | 2014-08-04 |
| Date of Event | 2013-02-27 |
| Date Mfgr Received | 2013-03-21 |
| Device Manufacturer Date | 2011-12-01 |
| Date Added to Maude | 2015-02-09 |
| 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 DR. |
| 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 | NEXWAVE |
| Product Code | IPF |
| Date Received | 2014-08-05 |
| Returned To Mfg | 2013-03-21 |
| 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 |
| Manufacturer Address | LONE TREE CO US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-08-05 |