MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2014-08-05 for ZYNEX manufactured by Zynex Medical.
[5316963]
The unit smelled like it was burning and felt hot.
Patient Sequence No: 1, Text Type: D, B5
[12970417]
Reporting due to a fda finding during an audit in 01/2014. No injury to the patient. Conclusion: the q28 component was the cause of the failure.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1723686-2014-00003 |
| MDR Report Key | 4445130 |
| Report Source | 04 |
| Date Received | 2014-08-05 |
| Date of Report | 2014-08-04 |
| Date of Event | 2012-10-01 |
| Date Mfgr Received | 2012-11-08 |
| Device Manufacturer Date | 2012-05-01 |
| 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 | 8004956670 |
| Single Use | 3 |
| Remedial Action | RL |
| 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 | 2012-05-10 |
| 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 80124 US 80124 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-08-05 |