FDA.reportPublic FDA data

MAUDE MDR 8220331

MDR report key
8220331
Report number
8030229-2019-00002
Event key
0
Event type
3
Date of event
2018-12-11
Date received
2019-01-04
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MS. SHAMA MOOMAN
Address
SAFETY MGMT DEPT, QUALITY MGMT SEIBU BLDG 2, 4TH FLOOR 1-11-2 KUSUNOKIDAI TOKOROZAWA, SAITAMA 359-8 JA
Report source
M
Manufacturer link flag
Y

Devices#

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

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-01-040

Event Narratives#

N

Patient 1

THE EEG TECH REPORTED THAT THE CASTER ON CART FOR THE EEG SYSTEM CAME OFF. THEY STATED THAT THE BOLT THAT HELD THE CASTER IN PLACE SHEERED AND CAUSED IT TO FALL OFF. NO PATIENT HARM OR INJURY REPORTED. 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.

D

Patient 1

THE EEG TECH REPORTED THAT THE CASTER ON CART FOR THE EEG SYSTEM CAME OFF. THEY STATED THAT THE BOLT THAT HELD THE CASTER IN PLACE SHEERED AND CAUSED IT TO FALL OFF. NO PATIENT HARM OR INJURY REPORTED.