• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION NEUROFAX ELECTROENCEPHALOGRAPH

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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. 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. Attempt #1: on 02/01/2021, emailed customer via microsoft outlook for all items under the no information section. No reply was received. Attempt #2: on 02/18/2021, emailed customer via microsoft outlook for all items under the no information section. No reply was received. Attempt #3: on 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. Attempt #1: on 02/01/2021, emailed customer via microsoft outlook for all items under the no information section. No reply was received. Attempt #2: on 02/18/2021, emailed customer via microsoft outlook for all items under the no information section. No reply was received. Attempt #3: on 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.
 
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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameNI
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 Key11356070
MDR Text Key266960345
Report Number8030229-2021-00094
Device Sequence Number1
Product Code OLT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
NI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 02/20/2021
1 Device was Involved in the Event
0 Patients were 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
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/22/2021
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

-
-