OtherIPF
ZYNEX
Received Feb 9, 2011 · Event occurred Jan 21, 2011
Report 1723686-2011-00002 · MDR key 1994419
Device
Product problems
- Electrostatic Discharge
Patient
Not reported
- Electric Shock
Narrative
Description of Event or Problem
PATIENT REPORTED HE GOT A SHOCK WHEN USING THE UNIT.
Additional Manufacturer Narrative
CONCLUSION: ALTHOUGH THE POPPING SENSATION WAS NOT AS NOTICEABLE ON CERTAIN INDIVIDUALS, IT COULD BE FELT BY 75% OF THOSE TESTED INTERNALLY AT ZYNEX. THE CONSENSUS WAS THAT IT COULD BE PERCEIVED AS AN UNPLEASANT SHOCK TO CERTAIN INDIVIDUALS MORE SENSITIVE TO ELECTRICAL STIMULATION AND WARRANTED CORRECTION.
Remedial action
- Replace