MalfunctionIPF
ZYNEX
Received Aug 5, 2014 · Event occurred Dec 11, 2012
Report 1723686-2014-00004 · MDR key 4445132
Device
Generic name
Nexwave
Manufacturer
Zynex MedicalProduct problems
- Charred
- Temperature Problem
Patient
Not reported
- No Information
Narrative
Additional Manufacturer Narrative
REPORTING DUE TO A FDA FINDING DURING AN AUDIT IN (B)(4) /2014. NO INJURY TO THE PATIENT. CONCLUSION: THE Q2 AND Q26 COMPONENTS WERE THE LIKELY CAUSE OF THE FAILURE, POSSIBLY CAUSED SOME INTERNAL SHORT IN THE BOARD.
Description of Event or Problem
THE UNIT SMELLED LIKE IT WAS BURNING.
Remedial action
- Replace