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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION EEG-1200A; NEUROFAX ELECTROENCEPHALOGRAPH
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NIHON KOHDEN CORPORATION EEG-1200A; NEUROFAX ELECTROENCEPHALOGRAPH Back to Search Results
Model Number EEG-1200A
Device Problems Overheating of Device (1437); Temperature Problem (3022)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/24/2021
Event Type  malfunction  
Manufacturer Narrative
The monitor technician reported that there was a burning smell from the system.They did some troubleshooting and found that the power supply inside the computer was causing the smell.They replaced the part with the nihon kohden provided part number for the replacement power supply.Issue was resolved by the customer.This was not in patient use and no other devices being used with the system.
 
Event Description
The monitor technician reported that there was a burning smell from the system.They did some troubleshooting and found that the power supply inside the computer was causing the smell.They replaced the part with the nihon kohden provided part number for the replacement power supply.Issue was resolved by the customer.This was not in patient use.
 
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Brand Name
EEG-1200A
Type of Device
NEUROFAX ELECTROENCEPHALOGRAPH
Manufacturer (Section D)
NIHON KOHDEN CORPORATION
attn: shama mooman
1-31-4 nishiochia
shinjuku-ku, tokyo 161-8 560
JA  161-8560
MDR Report Key12222736
MDR Text Key269587149
Report Number2080783-2021-01464
Device Sequence Number1
Product Code OLT
UDI-Device Identifier04931921110904
UDI-Public4931921110904
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 07/24/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/24/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberEEG-1200A
Device Catalogue NumberEEG-1200A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/24/2021
Distributor Facility Aware Date06/24/2021
Device Age80 MO
Event Location Hospital
Date Report to Manufacturer07/24/2021
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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