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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION; NEUROFAX ELECTROENCEPHALOGRAPH
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NIHON KOHDEN CORPORATION; NEUROFAX ELECTROENCEPHALOGRAPH Back to Search Results
Device Problems Display or Visual Feedback Problem (1184); Application Program Problem (2880)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/22/2021
Event Type  malfunction  
Manufacturer Narrative
The doctor reported that a patient was seizing and that they were unable to remote into the acquisition eeg unit to view the eeg in progress.They were using a rdp (remote desktop protocol) into a review station that is 20 miles from their home.By connecting to a review station, the user can then connect to the acquisition eeg that is connected to the patient and doing the physical eeg monitoring on the patient.Nihon kohden technical support (tech support) was able to remote into the doctor's machine and observe the issue.Nwb (nueroworkbench) was not connected to the database.Tech support opened services and both sql services were not running.Tech support started the services and relaunched nwb; and the issue was resolved.The customer would not let tech support further troubleshoot to see what could have possibly happened to turned off the sql.Attempt #1: 02/01/2021- emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #2: 02/18/2021 - emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #3: 02/19/2021 - emailed customer via microsoft outlook for all items under the no information section.The customer replied back with other issues and did not provide patient or additional device information.Additional device information: concomitant medical device field contains no information (ni), as attempts to obtain information were made, but not provided.
 
Event Description
The doctor reported that a patient was seizing and that they were unable to remote into the acquisition eeg unit to view the eeg in progress.They were using a rdp (remote desktop protocol) into a review station that is 20 miles from their home.By connecting to a review station, the user can then connect to the acquisition eeg that is connected to the patient and doing the physical eeg monitoring on the patient.Nihon kohden technical support (tech support) was able to remote into the doctor's machine and observe the issue.Nwb (nueroworkbench) was not connected to the database.Tech support opened services and both sql services were not running.Tech support started the services and relaunched nwb; and the issue was resolved.
 
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Brand Name
NI
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 Key11356071
MDR Text Key266592371
Report Number2080783-2021-00094
Device Sequence Number1
Product Code OLT
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 02/20/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/20/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/20/2021
Distributor Facility Aware Date01/22/2021
Event Location Hospital
Date Report to Manufacturer02/20/2021
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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