MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2015-02-11 for ZYNEX manufactured by Zynex Medical Inc.
[19719473]
Unit gets hot. Use to be able to use one battery every 24hrs, now it's 3 batteries every 24 hrs. Unit gets so hot it's unbearable. Patient is experiencing more surge shocks now.
Patient Sequence No: 1, Text Type: D, B5
[19864012]
Reporting due to an fda findings during audit in 1/2015. Investigation and results; unit turned on, passed final testing without any problems. Left unit running for 30 minutes at 31ma on both channels (tens mode) and had no heat issue. Could not duplicate patients complaint.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1723686-2015-00001 |
| MDR Report Key | 4574819 |
| Report Source | 04 |
| Date Received | 2015-02-11 |
| Date of Report | 2015-02-05 |
| Date of Event | 2013-10-03 |
| Date Mfgr Received | 2013-10-03 |
| Device Manufacturer Date | 2011-11-14 |
| Date Added to Maude | 2015-03-17 |
| 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 | 2015-02-11 |
| Returned To Mfg | 2013-10-11 |
| 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 | 2015-02-11 |