OtherIPF
ZYNEX
Received Feb 9, 2011 · Event occurred Jan 21, 2011
Report 1723686-2011-00001 · MDR key 1994420
Device
Product problems
- Electrostatic Discharge
Patient
Not reported
- Electric Shock
Narrative
Additional Manufacturer Narrative
CONCLUSION: IT IS INCONCLUSIVE EXACTLY HOW THE PATIENT EXPERIENCED A SHOCKING SENSATION. ON-SKIN EVALUATION OF THE UNIT IN STRENGTH DURATION MODE REVEALED SOME UNPLEASANTNESS ON THE LEFT FOREARM. WHETHER THE PATIENT EXPERIENCED THAT SORT OF SENSATION OR SOMETHING WORSE IS INCONCLUSIVE.
Description of Event or Problem
PATIENT REPORTED HE GOT A SHOCK WHEN USING THE UNIT.
Remedial action
- Replace