EEG-1200A
Received Dec 6, 2017 · Event occurred Nov 7, 2017
Report 8030229-2017-00424 · MDR key 7087049
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 Known Impact Or Consequence To Patient
- No Consequences Or Impact To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
ADDITIONAL INFORMATION: TYPE OF REPORT? IF FOLLOW-UP, WHAT TYPE? DETAILS OF COMPLAINT: CUSTOMER CALLED AND REPORTED HER EEG/POLYSMITH SYSTEM 'POPPED AND STARTED SMELLING LIKE SOMETHING WAS BURNT. UNIT WAS SENT IN FOR EVALUATION. SERVICE REQUESTED: REPAIR/LOANER. SERVICE PERFORMED: TROUBLESHOOTING. INVESTIGATION RESULT: REVIEWED THE PC WITH REPAIR CENTER AND THE COMPUTER WOULD NOT TURN ON, ONLY THE AMBER LIGHT WAS FLASHING. THERE WAS NO BURNING SMELL. REQUESTED THE REPAIR CENTER CONTINUE WITH TROUBLESHOOTING PC. QA/REPAIR CENTER HAS EVALUATED THE BURNING SMELL THAT CAME FROM POWER SUPPLY BURNING. REPLACE THE POWER SUPPLY. REAPPLY THE CPU PASTE. CHECK THE EEG TEST.
Additional Manufacturer Narrative
THE EEG TECH REPORTED THE EEG / PSG COMBO SYSTEM "POPPED AND STARTED SMELLING LIKE SOMETHING WAS BURNT." QA ALONG WITH SERVICE REVIEWED THE PC AND THE COMPUTER WOULD NOT TURN ON, ONLY THE AMBER LIGHT WAS FLASHING. THERE WAS NOT BURNING SMELL. THE UNIT WAS THEN EVALUATED BY THE SERVICE, AND THEY CONCLUDED THAT THE POWER SUPPLY WAS BAD. THE POWER SUPPLY WAS REPLACED AND THE UNIT WAS BURNED-IN FOR 72 HOURS AND EVERYTHING TESTED FINE. NIHON KOHDEN WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Description of Event or Problem
THE EEG TECH REPORTED THE EEG / PSG COMBO SYSTEM "POPPED AND STARTED SMELLING LIKE SOMETHING WAS BURNT."