MalfunctionIPF
ZYNEX
Received Feb 11, 2015 · Event occurred Jun 26, 2014
Report 1723686-2015-00006 · MDR key 4574816
Device
Generic name
Truwave Plus
Manufacturer
Zynex Medical IncProduct problems
- Charred
- Temperature Problem
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
UNIT IS BURNING AND PATIENT IS GETTING CHANNEL ELE ERRORS, HE USES THE TENS UNIT ON 25-30MA'S.
Additional Manufacturer Narrative
REPORTING DUE TO FDA FINDINGS DURING AUDIT IN 1/2015. INVESTIGATION AND RESULTS: UNIT ARRIVED IN IFC-LOWHIGH, 40 MINUTES. (B)(4). THIS UNIT DRAWS EXCESSIVE CURRENT; Q26 AND Q3 ARE DAMAGED DUE TO OVERHEATING. ELECTRODE WIRES AND POWER SUPPLY ARE FUNCTIONING PROPERLY.
Remedial action
- Replace