MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION; NEUROFAX ELECTROENCEPHALOGRAPH

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.

Manufacturer Narrative

Details of complaint: the doctor reported that a patient was seizing, and they were unable to remote into the acquisition eeg system to view the in-progress eeg study.They were using an rdp (remote desktop protocol) to see the study from the review station 20 miles away.Nihon kohden technical support (nk ts) was able to remote into the doctor's machine and found that the nueroworkbench (nwb) software was not connected to the database.Both sql services were not running.Nk ts started the services and relaunched nwb, which resolved the issue.Service requested / performed: troubleshooting.Investigation summary: there is no evidence of design or manufacturing deficiencies that would contribute to improper configuration.Intermittent software issues can often be resolved by restarting the software or computer the software is running on.Many factors can contribute to a software's ability to perform certain actions such as processing bandwidth, connection hang ups, unresponsive applications/services, etc.Should these issues be resolved through restart, it is unlikely that the issue occurred as a result of a deficiency of the software.These intermittent software issues are monitored for repeatability.Radmin is a third-party remote accessing software and is not a product designed, manufactured, or distributed by nk.

Event Description

The doctor reported that a patient was seizing, and they were unable to remote into the acquisition eeg system to view the in-progress eeg study.They were using an rdp (remote desktop protocol) to see the study from the review station 20 miles away.Nihon kohden technical support (nk ts) was able to remote into the doctor's machine and found that the nueroworkbench (nwb) software was not connected to the database.Both sql services were not running.

• 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
• 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 Key: 11356070
• MDR Text Key: 266960345
• Report Number: 8030229-2021-00094
• Device Sequence Number: 1
• Product Code: OLT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2021
• 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
• Date Manufacturer Received: 11/21/2022
• 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
• Patient Sequence Number: 1