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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. 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.
 
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 NameEEG-1200A
Type of DeviceNEUROFAX 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 Key12222735
MDR Text Key281999253
Report Number8030229-2021-01464
Device Sequence Number1
Product Code OLT
Combination Product (y/n)N
PMA/PMN Number
K080546
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial
Report Date 07/24/2021
1 Device was Involved in the Event
0 Patients were 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
Device Model NumberEEG-1200A
Device Catalogue NumberEEG-1200A
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/24/2021
Is This a Reprocessed and Reused Single-Use Device? No

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