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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 11/01/2021
Event Type  malfunction  
Manufacturer Narrative
The biomedical engineer (bme) reported that back in 11/2021, it was reported to them that the ir (infra red) illuminator sparked and gave off some smoke. The system was turned off immediately, and they determined it was the ir illuminator. They continued to use the eeg system without using the illuminator until now. However, one of the doctors needs it working. This is not an issue with the eeg itself but with the third party ir illuminator manufactured by bosch. This device was not in patient use. 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. Additional device information: concomitant medical device: the following device(s) were being used in conjunction with the eeg. Bosch ir illuminator, third party device model: iir-50850-sr. Sn: (b)(4).
 
Event Description
The biomedical engineer (bme) reported that back in 11/2021, it was reported to them that the ir (infra red) illuminator sparked and gave off some smoke. The system was turned off immediately, and they determined it was the ir illuminator. They continued to use the eeg system without using the illuminator until now. However, one of the doctors needs it working. This is not an issue with the eeg itself but with the third party ir illuminator manufactured by bosch. This device 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
Manufacturer (Section G)
NIHON KOHDEN TOMIOKA CORPORATION
attn: shama mooman
1-1 tajino
tomioka city, gunma 370-2 314
JA 370-2314
Manufacturer Contact
shama mooman
safety mgmt dept, quality mgmt
seibu bldg 2, 4th floor 1-11-2
kusunokidai tokorozawa, saitama 359-8-580
JA   359-8580
MDR Report Key13466880
MDR Text Key285432219
Report Number8030229-2022-02450
Device Sequence Number1
Product Code OLT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K080546
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 02/05/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/05/2022
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
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/07/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/04/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 02/05/2022 Patient Sequence Number: 1
Treatment
BOSCH IR ILLUMINATOR
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