MalfunctionIPF
ZYNEX
Received Feb 11, 2015 · Event occurred Oct 3, 2013
Report 1723686-2015-00001 · MDR key 4574819
Device
Generic name
Nexwave
Manufacturer
Zynex Medical IncProduct problems
- Charred
- Temperature Problem
Patient
Not reported
- Electric Shock
Narrative
Description of Event or Problem
UNIT GETS HOT. USE TO BE ABLE TO USE ONE BATTERY EVERY 24HRS, NOW IT'S 3 BATTERIES EVERY 24 HRS. UNIT GETS SO HOT IT'S UNBEARABLE. PATIENT IS EXPERIENCING MORE SURGE SHOCKS NOW.
Additional Manufacturer Narrative
REPORTING DUE TO AN FDA FINDINGS DURING AUDIT IN 1/2015. INVESTIGATION AND RESULTS; UNIT TURNED ON, PASSED FINAL TESTING WITHOUT ANY PROBLEMS. LEFT UNIT RUNNING FOR 30 MINUTES AT 31MA ON BOTH CHANNELS (TENS MODE) AND HAD NO HEAT ISSUE. COULD NOT DUPLICATE PATIENTS COMPLAINT.
Remedial action
- Replace