MalfunctionIPF
ZYNEX
Received Feb 11, 2015 · Event occurred Mar 17, 2014
Report 1723686-2015-00003 · MDR key 4574818
Device
Generic name
Nexwave
Manufacturer
Zynex Medical IncProduct problems
- Charred
- Temperature Problem
Patient
Not reported
- Device Overstimulation of Tissue
Narrative
Description of Event or Problem
PATIENT REPORTED RECEIVING EXCESS STIMULATION WHEN UNIT IS POWERED ON. UNIT INCREASES EXCESSIVELY IN STIM ON IT'S OWN.
Additional Manufacturer Narrative
REPORTING DUE TO FDA FINDINGS DURING AUDIT IN 01/2015. INVESTIGATION AND RESULTS: UNIT TURNED ON, PASSED FINAL TESTING WITHOUT ANY PROBLEMS. LEFT UNIT RUNNING FOR 25 MINUTES AT 23MA (TENS MODE) AND HAD NO EXCESSIVE INCREASE ON IT'S OWN. COULD NOT DUPLICATE PATIENTS COMPLAINT. NO PROBLEM FOUND.
Remedial action
- Replace