FDA.reportPublic FDA data

MAUDE MDR 6111890

MDR report key
6111890
Report number
8030229-2016-00543
Event key
0
Event type
3
Date of event
2016-10-18
Date received
2016-11-18
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
401
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
SUSAN SHADLEY
Address
1-31-4 NISHIOCHIAI, SHINJUKU-K ATTN: SUSAN SHADLEY TOKYO, JAPAN 161-8 JA
Phone
268-268-2687
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1EEG-1200ANEUROFAX ELECTROENCEPHALOGRAPHNIHON KOHDEN TOMIOKA CORPORATIONOLTEEG-1200AEEG-1200AY R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12016-11-180

Event Narratives#

N

Patient 1

THE BIOMEDICAL ENGINEER REPORTS THAT THE DEVICE WILL NOTE TURN ON AND ACTUALLY SMOKED AT ONE POINT. 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.

D

Patient 1

THE BIOMEDICAL ENGINEER REPORTS THAT THE DEVICE WILL NOTE TURN ON AND ACTUALLY SMOKED AT ONE POINT.

N

Patient 1

MANUFACTURER NARRATIVE: THE BIOMEDICAL ENGINEER REPORTED THAT THE (B)(4) 9010 PC COMPONENT OF THE EEG-1200A SYSTEM WOULD NOT POWER ON AND BEGAN TO SMOKE. THE COMPUTER WAS SENT TO NIHON KOHDEN FOR EVALUATION AND REPAIR, HOWEVER DAMAGE TO THE COMPUTER'S PLASTIC COVER, WHICH IS A PART NIHON KOHDEN CANNOT ORDER, PREVENTED THE REPAIR OF THE COMPUTER. THE CUSTOMER WAS PROVIDED WITH A REPLACEMENT COMPUTER. NIHON KOHDEN CONTINUES TO INVESTIGATE THE REPORTED EVENT. NIHON KOHDEN WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE.