EEG-1200A

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-05-16 for EEG-1200A manufactured by Nihon Kohden Corporation.

Event Text Entries

[108479559] The customer reported that a patient had expired while being connected to our machine. No malfunction of the eeg device was reported. 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.
Patient Sequence No: 1, Text Type: N, H10


[108479560] The customer reported that a patient had expired while being connected to our machine.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number8030229-2018-00158
MDR Report Key7520252
Report SourceUSER FACILITY
Date Received2018-05-16
Date of Report2018-05-16
Date of Event2018-04-19
Date Facility Aware2018-04-19
Report Date2018-05-16
Date Reported to FDA2018-05-16
Date Reported to Mfgr2018-05-16
Date Mfgr Received2018-05-16
Date Added to Maude2018-05-16
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag0
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactSHAMA MOOMAN
Manufacturer StreetSAFETY MGMT DEPT, QUALITY MGMT SEIBU BLDG 2, 4TH FLOOR 1-11-2
Manufacturer CityKUSUNOKIDAI TOKOROZAWA, SAITAMA 359-8580
Manufacturer CountryJA
Manufacturer Postal359-8580
Manufacturer G1NIHON KOHDEN TOMIOKA CORPORATION
Manufacturer Street1-1 TAJINO ATTN: SHAMA MOOMAN
Manufacturer CityTOMIOKA CITY, GUNMA 370-2314
Manufacturer CountryJA
Manufacturer Postal Code370-2314
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameEEG-1200A
Generic NameNEUROFAX ELECTROENCEPHALOGRAPH
Product CodeOLT
Date Received2018-05-16
Model NumberEEG-1200A
Catalog NumberEEG-1200A
Lot NumberNOT APPLICABLE
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Age34 MO
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerNIHON KOHDEN CORPORATION
Manufacturer Address1-31-4 NISHIOCHIA, SHINJUKU-KU ATTN: SHAMA MOOMAN TOKYO, 161-8560 JA 161-8560


Patients

Patient NumberTreatmentOutcomeDate
101. Death 2018-05-16

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