EEG-1200A
Received Jul 24, 2021 · Event occurred Jun 24, 2021
Report 8030229-2021-01464 · MDR key 12222735
Device
Generic name
Neurofax Electroencephalograph
Manufacturer
Nihon Kohden CorporationModel number
EEG-1200ACatalog number
EEG-1200A
Lot number
NA
Product problems
- Overheating of Device
- Temperature Problem
- Overheating of Device
- Temperature Problem
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE MONITOR TECHNICIAN REPORTED THERE WAS A BURNING SMELL COMING 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.
Additional Manufacturer Narrative
DETAILS OF COMPLAINT: THE MONITOR TECHNICIAN REPORTED THERE WAS A BURNING SMELL COMING FROM THE SYSTEM. THEY PERFORMED SOME TROUBLESHOOTING AND FOUND THAT THE POWER SUPPLY INSIDE THE COMPUTER WAS CAUSING THE SMELL. NO HARM OR INJURY WAS REPORTED. INVESTIGATION SUMMARY: THE CUSTOMER REPORTED THAT THE ISSUE WAS RESOLVED BY REPLACING THE POWER SUPPLY ON THE PC. THE DEVICE WAS INSTALLED AT THE CUSTOMER'S FACILITY ON APPROXIMATELY 10/2014. THE DEVICE WAS NOT RETURNED FOR EVALUATION, SO A ROOT CAUSE CANNOT BE DETERMINED. DUE TO THE AGE OF THE DEVICE, THE ROOT CAUSE IS MOST LIKELY RELATED TO WEAR AND TEAR AND AGING OF THE POWER SUPPLY. COMPLAINT HISTORY REVIEW REVEALED THAT THIS IS INCIDENT IS THE ONLY INCIDENT REGARDING SMELL TO HAVE OCCURRED WITH EEG SYSTEMS. THIS IS DEEMED TO BE AN ISOLATED INCIDENT. NO FURTHER ISSUES WERE REPORTED. ADDITIONAL INFORMATION: B4 DATE OF THIS REPORT G3 DATE RECEIVED BY MANUFACTURER G6 TYPE OF REPORT H2 IF FOLLOW-UP, WHAT TYPE? H6 EVENT PROBLEM AND EVALUATION CODES.
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. NIHON KOHDEN CONTINUES TO INVESTIGATE THE REPORTED EVENT. NIHON KOHDEN WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.
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.