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MEM-4104K

Received Apr 29, 2002 · Event occurred Mar 6, 2002

Report 2080783-2002-00001 · MDR key 391518

Device

Generic name

Ep/emg

Manufacturer

Nihon Kohden

Model number

MEM4104-K

Catalog number

*

Lot number

*

Product problems

  • Device Issue

Patient

41 YR

  • Bruise/Contusion
  • Burn(s)
  • Unknown (for use when the patient's condition is not known)

Narrative

Description of Event or Problem

ELECTRICAL STIMULATION WAS NOT WORKING. ELECTRODES CONTACTS CREATED SUPERFICIAL SKIN BURNS ON THE PT AND LATER ON THE TECH WHEN THEY TRIED TO DUPLICATE THE ABR PROCEDURE ON THEMSELVES. THE PT DID NOT COMPLAINT ABOUT THE BURN BUT CLAIMED OF SLIGHT STINGING ON THEIR RIGHT EAR DURING AUDITORY TESTING. THE ELECTRODES WERE NOT MFG BY NKC. NO INFO ON THE ELECTRODES CONDITION IS AVAILABLE. THE PRODUCT HAS BEEN OBSOLETE SINCE 12/1992.