MalfunctionIPF
ZYNEX
Received Mar 13, 2015 · Event occurred Aug 4, 2014
Report 1723686-2015-00009 · MDR key 4613398
Device
Product problems
- Inappropriate/Inadequate Shock/Stimulation
Patient
Not reported
- Shock from Patient Lead(s)
Narrative
Description of Event or Problem
DEVICE IS SHOCKING PATIENT EVEN WITH NEW PADS AND LEAD WIRES.
Additional Manufacturer Narrative
ZYNEX: PATIENT DID NOT RETURN AC ADAPTER OR LEAD WIRES. UNIT TURNED ON, PASSED FINAL TESTING WITHOUT ANY PROBLEMS. NO PROBLEM FOUND.
Remedial action
- Replace