EEG-1200A
Received Mar 20, 2017 · Event occurred Feb 22, 2017
Report 8030229-2017-00079 · MDR key 6419646
Device
Generic name
Neurofax Electroencephalograph
Manufacturer
Nihon Kohden CorporationModel number
EEG-1200ACatalog number
EEG-1200A
Product problems
- Smoking
- Smoking
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
THE CUSTOMER REPORTS THAT WHEN THE DEVICE WAS TURNED ON IT MADE A POP SOUND AND STARTING SMOKING. THE DEVICE WILL NOT TURN ON. NO PATIENT HARM WAS REPORTED. CUSTOMER REPLACED THE POWER SUPPLY. SINCE REPLACING THE POWER SUPPLY, NO ISSUES HAVE BEEN REPORTED. NIHON KOHDEN WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE. RESOLVED AT FACILITY.
Description of Event or Problem
THE CUSTOMER REPORTS THAT WHEN THE DEVICE WAS TURNED ON IT MADE A POP SOUND AND STARTING SMOKING. THE DEVICE WILL NOT TURN ON.