MalfunctionIPF
ZYNEX
Received Dec 3, 2014 · Event occurred Nov 6, 2014
Report 1723686-2014-00008 · MDR key 4621115
Device
Generic name
Combo Electrical Stimulator, Ipf, Gzj, Lih
Manufacturer
Zynex Medical, Inc.Model number
NEXWAVEProduct problems
- Insufficient Device Problem Information
Patient
49 YR
- Burn(s)
- Erythema
Narrative
Description of Event or Problem
PT REPORTED UNIT BURNED HER (LOWER BACK AREA). SHE CAME TO THE MAIN OFFICE, DROPPED THE UNIT OFF IN PERSON AND SHOWED THE REDNESS ON HER LOWER BACK TO THE QUAL MGR. SEE SCANNED PAGES.
Remedial action
- Other