MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2009-06-16 for ZYNEX IF 8000 manufactured by Zynex Medical.
[1265951]
Patient stated that when the device was turned on, it felt like it was burning and shocking him.
Patient Sequence No: 1, Text Type: D, B5
[8437565]
This is being reported at the recommendation of (b)(6) , fda investigator after an inspection of zynex medical on 6/3/09-6/10/09. Conclusion: 6/9/08. Pcb inspected, tested and reworked by (b)(4). Removed q31. Pads for pins 1 and 2 had disintegrated and could not be salvaged. Soldered in new (b)(4) (only pin 3). Removed q30, (b)(4) and replaced it with (b)(4). Soldered in short, 30 awg jumpers between q31-2 and q30-2, and between q31-1 and q30-3. Burned in for 60 minutes using 12 vdc supply connected to ac adapter jack. Starting current draw was 400 ma. Output was 42 v peak. Ending current draw was 36- ma. Tested electrode alarm at 4, 20 and 50 ma. Would only work at 4 ma. Implemented balance of eco 1023. Note: (b)(4) swap out with (b)(4) was part of eco 1023. Quick test of current draw and electrode alarm capability did not reveal any significant change. Reassembled unit. Unit released to the repair area for processing into the used inventory. Corrective action: unit will be updated per eco 1023. New rev of board that is in the test and prototype phase, will eliminate this problem from occurring.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1723686-2009-00002 |
| MDR Report Key | 1403891 |
| Report Source | 99 |
| Date Received | 2009-06-16 |
| Date of Report | 2009-06-16 |
| Date of Event | 2008-03-31 |
| Device Manufacturer Date | 2008-02-15 |
| Date Added to Maude | 2010-08-21 |
| 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 | 8022 SOUTHPARK CIRCLE,UNIT 100 |
| Manufacturer City | LITTLETON CO 80120 |
| Manufacturer Country | US |
| Manufacturer Postal | 80120 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ZYNEX |
| Generic Name | INTERFERENTIAL ELECTRICAL STIMULATOR |
| Product Code | LIH |
| Date Received | 2009-06-16 |
| Returned To Mfg | 2008-06-03 |
| Model Number | IF 8000 |
| 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 | LITTLETON CO US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2009-06-16 |