inforMED
MalfunctionOLT

EEG-1200A

Received Jul 24, 2021 · Event occurred Jun 24, 2021

Report 2080783-2021-01464 · MDR key 12222736

Device

Generic name

Neurofax Electroencephalograph

Model number

EEG-1200A

Catalog number

EEG-1200A

Lot number

NA

Product problems

  • Overheating of Device
  • Temperature Problem
  • Overheating of Device
  • Temperature Problem

Patient

Not reported

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Additional Manufacturer Narrative

THE MONITOR TECHNICIAN REPORTED THAT THERE WAS A BURNING SMELL FROM THE SYSTEM. THEY DID SOME TROUBLESHOOTING AND FOUND THAT THE POWER SUPPLY INSIDE THE COMPUTER WAS CAUSING THE SMELL. THEY REPLACED THE PART WITH THE NIHON KOHDEN PROVIDED PART NUMBER FOR THE REPLACEMENT POWER SUPPLY. ISSUE WAS RESOLVED BY THE CUSTOMER. THIS WAS NOT IN PATIENT USE AND NO OTHER DEVICES BEING USED WITH THE SYSTEM.

Description of Event or Problem

THE MONITOR TECHNICIAN REPORTED THAT THERE WAS A BURNING SMELL FROM THE SYSTEM. THEY DID SOME TROUBLESHOOTING AND FOUND THAT THE POWER SUPPLY INSIDE THE COMPUTER WAS CAUSING THE SMELL. THEY REPLACED THE PART WITH THE NIHON KOHDEN PROVIDED PART NUMBER FOR THE REPLACEMENT POWER SUPPLY. ISSUE WAS RESOLVED BY THE CUSTOMER. THIS WAS NOT IN PATIENT USE.