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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 Problem Power Problem (3010)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/24/2021
Event Type  malfunction  
Manufacturer Narrative
The customer reported that their computer turning off unexpectedly during a surgical case. The customer also reported that they were able to recover with minimal data loss and continue recording, but only after having a tech go into the room and turn the recorder back on. No harm or injury was reported. Nihon kohden continues to investigate the reported event. Additional model information: device available for evaluation: the following non-nkc device was used in conjunction with the eeg-1200a: model: a/dell-7050sff s/n: (b)(4).
 
Event Description
The customer reported that their computer turning off unexpectedly during a surgical case. The customer also reported that they were able to recover with minimal data loss and continue recording, but only after having a tech go into the room and turn the recorder back on.
 
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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 Key11572948
MDR Text Key245979732
Report Number8030229-2021-00174
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 other,user facility
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 03/25/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/25/2021
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
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/24/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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