EPOCH XP
Received Sep 28, 2010 · Event occurred May 11, 2010
Report 1865027 · MDR key 1865027
Device
Generic name
Stimulator, Photic, Evoked Response
Manufacturer
Axon SystemsModel number
EPOCH XPCatalog number
EPOCH XP
Lot number
*
Product problems
- Fluid/Blood Leak
- Electrical Shorting
Patient
46 YR
- Superficial (First Degree) Burn
Narrative
Description of Event or Problem
THE TECHNICIAN PLACED THE UNIT AT THE FRONT OF THE HEAD OF THE PATIENT; THE UNIT IS MANUFACTURED WITHOUT PROTECTION OF OVERSPRAY FROM SUCTION IRRIGATION SO WHEN THE UNIT WAS SPRAYED, IT SHORTED OUT SOME OF THE ELECTRODES AND CAUSED FIRST DEGREE BURNS TO THE PATIENT'S EAR, BACK AND SCALP.======================HEALTH PROFESSIONAL'S IMPRESSION======================DID NOT REALIZE THE UNIT WAS NOT COVERED BY THE STERILE DRAPING; THEREFORE, DID NOT NOTICE THE BURNING TO THE PATIENT.