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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  
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.
 
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. The following non-nkc device was used in conjunction with the eeg-1200a: model: a/dell-7050sff s/n: (b)(4).
 
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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 Key11571856
MDR Text Key280475746
Report Number2080783-2021-00174
Device Sequence Number1
Product Code OLT
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Type of Report Initial
Report Date 03/25/2021
1 Device was Involved in the Event
1 Patient was 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
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/25/2021
Distributor Facility Aware Date02/24/2021
Event Location Hospital
Date Report to Manufacturer03/25/2021
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 03/25/2021 Patient Sequence Number: 1
Treatment
A/DELL-7050SFF-W10
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