MalfunctionIPF
ZYNEX
Received Aug 5, 2014 · Event occurred Oct 1, 2012
Report 1723686-2014-00003 · MDR key 4445130
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 01/2014. NO INJURY TO THE PATIENT. CONCLUSION: THE Q28 COMPONENT WAS THE CAUSE OF THE FAILURE.
Description of Event or Problem
THE UNIT SMELLED LIKE IT WAS BURNING AND FELT HOT.
Remedial action
- Replace