Device Problems
Display or Visual Feedback Problem (1184); Application Program Problem (2880)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/22/2021 |
Event Type
malfunction
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Manufacturer Narrative
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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.
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Event Description
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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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Manufacturer Narrative
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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.
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Event Description
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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.
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Search Alerts/Recalls
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