inforMED
MalfunctionOLT

NI

Received Feb 20, 2021 · Event occurred Jan 22, 2021

Report 2080783-2021-00094 · MDR key 11356071

Device

Generic name

Neurofax Electroencephalograph

Model number

NI

Catalog number

NI

Lot number

NA

Product problems

  • Display or Visual Feedback Problem
  • Application Program Problem
  • Display or Visual Feedback Problem
  • Application Program Problem

Patient

Not reported

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Additional 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.

Description of Event or Problem

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.