EEG-1200A

Additional Manufacturer Narrative

THE CUSTOMER REPORTED THAT THE EEG DATA RECORDED UNDER ANOTHER PATIENT'S STUDY NODE. NO PATIENT HARM OR INJURY REPORTED. NIHON KOHDEN CONTINUES TO INVESTIGATE THE REPORTED EVENT. NIHON KOHDEN WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

Description of Event or Problem

THE CUSTOMER REPORTED THAT THE EEG DATA RECORDED UNDER ANOTHER PATIENT'S STUDY NODE. NO PATIENT HARM OR INJURY REPORTED.

Additional Manufacturer Narrative

DETAILS OF COMPLAINT: ON (B)(6) 2019 THE CUSTOMER STATED THE EEG DATA FILED UNDER WRONG NODE. CUSTOMER CALLED TO REPORT THAT HE HAD A STUDY THAT INCORRECTLY FILED DATA UNDER THE WRONG NODE. HE STATED THAT WHEN THE STUDY WAS RUNNING 2 WEEKS THE PATIENT'S NAME WAS THE DATA FILED CORRECTLY. HE NOTICED THAT A PATIENT WHO WAS DONE LAST WEEK, NOW HAD BEEN FILED UNDER THE AFOREMENTIONED PATIENT'S NAME. SERVICE REQUESTED: TROUBLESHOOTING. SERVICE PERFORMED: TROUBLESHOOTING. INVESTIGATION RESULT: REMOTED INTO THE ACQUISITION UNIT AND WENT BACK TO THE SCHEDULE DATE 2 WEEKS AGO; THE PATIENT WAS NO LONGER ON THE SCHEDULE. CUSTOMER WAS REQUESTED TO CREATE A NEW SCHEDULE AND CHANGED THE DB KEY, SO THE EEG DATA WAS NOW UNDER THE CORRECT NAME. WENT TO THE WINDOWS LOGS AND NOTICED THAT THIS ACQUISITION UNIT HAD MULTIPLE UNGRACEFUL EXITS. CUSTOMER WAS EXPLAINED THAT THIS COULD BE RELATED TO THE ISSUES HE EXPERIENCED. HE AGREED TO THIS EXPLANATION. THERE WAS NO PATIENT HARM AND THE SOFTWARE DID NOT MALFUNCTION.

Description of Event or Problem

THE CUSTOMER REPORTED THAT THE EEG DATA RECORDED UNDER ANOTHER PATIENT'S STUDY NODE. NO PATIENT HARM OR INJURY REPORTED.

Additional Manufacturer Narrative

H10: ADDITIONAL NARRATIVE: ON (B)(6) 2019 THE CUSTOMER STATED THE EEG DATA FILED UNDER WRONG NODE. BARRY CALLED TO REPORT THAT HE HAD A STUDY THAT INCORRECTLY FILED DATA UNDER THE WRONG NODE. HE STATED THAT WHEN THE STUDY WAS RUNNING 2WEEKS THE PATIENT'S NAME WAS THE DATA FILED CORRECTLY. HE NOTICED THAT A PATIENT WHO WAS DONE LAST WEEK, NOW HAD BEEN FILED UNDER THE AFOREMENTIONED PATIENT'S NAME. SERVICE REQUESTED TROUBLESHOOTING. SERVICE PERFORMED TROUBLESHOOTING. INVESTIGATION RESULT: REMOTED INTO THE ACQUISITION UNIT. I WAS ABLE TO OBSERVE THE ISSUE. WE WENT BACK TO THE SCHEDULE DATE 2 WEEKS AGO; THE PATIENT WAS NO LONGER ON THE SCHEDULE. WE CREATED A NEW SCHEDULE AND CHANGED THE DB KEY, SO THE EEG DATA WAS NOW UNDER THE CORRECT NAME. WE WENT TO THE WINDOWS LOGS AND NOTICED THAT THIS ACQUISITION UNIT HAD MULTIPLE UNGRACEFUL EXITS. I EXPLAINED THAT THIS COULD BE RELATED TO THE ISSUES HE EXPERIENCED. HE AGREED TO THIS EXPLANATION. THERE WAS NO PATIENT HARM AND THE SOFTWARE DID NOT MALFUNCTION. NO FURTHER INVESTIGATION IS REQUIRED AND THE CASE CAN BE CLOSED AS THE CURRENT INFORMATION IN THE COMPLAINT RECORD DEMONSTRATES THAT THE ISSUE HAS BEEN RESOLVED BY STANDARD TROUBLESHOOTING WITH THE CUSTOMER. CORRECTED INFORMATION: F9. APPROXIMATE AGE OF DEVICE: INCORRECTLY CALCUATED G4. DATE RECEIVED BY MANUFACTURER: SHOULD BE 11/06/2018 NOT 12/04/2018 AS LISTED ON MDR INITIAL REPORT

Additional Manufacturer Narrative

H10: ADDITIONAL NARRATIVE: DETAILS OF THE COMPLAINT: ON (B)(6) 2018, CUSTOMER AT (B)(6) REPORTED THAT EEG DATA WAS FILLED UNDER WRONG NODE ON A/DELL-7040SFF WITH SERIAL# (B)(6). SERVICE REQUESTED: ASSISTANCE IN TROUBLESHOOTING . SERVICE PERFORMED: NK TECHNICAL SUPPORT COULD DUPLICATE THE ISSUE AND ASSISTED IN TROUBLESHOOTING. NKTS WENT BACK ON SCHEDULE DATED TWO WEEKS FROM REPORTED ISSUE; PATIENT WAS NO LONGER ON SCHEDULE. THE ISSUE WAS RESOLVED BY CREATING A NEW SCHEDULE AND CHANGING DATABASE KEY, TO PREVENT FILE FROM BEING SAVED ON WRONG NODE. THE ROOT CAUSE OF THE ISSUE WAS IDENTIFIED TO BE MULTIPLE UNGRACEFUL SHUTDOWNS FROM THE EVENT LOG. THE ISSUE WAS RESOLVED. REVIEW OF DEVICE SAP HISTORY FOUND NO PREVIOUSLY REPORTED AUDIO ALARM ISSUES WITH THE UNIT. THE WARRANTY OF THE DEVICE EXPIRED ON 09/17/2011. INVESTIGATION RESULT(S): ROOT CAUSE OF THE ISSUE WAS IDENTIFIED TO BE MULTIPLE UNGRACEFUL SHUTDOWNS FROM THE EVENT LOG. REVIEW OF DEVICE SAP HISTORY FOUND NO PREVIOUSLY REPORTED AUDIO ALARM ISSUES WITH THE UNIT. THE WARRANTY OF THE DEVICE EXPIRED ON 09/17/2011. ACCORDING TO PRODUCT HISTORY OF A/DELL-7040SFF, 10 SIMILAR ISSUES HAVE BEEN REPORTED AS OF 1/5/2020 RELATED TO EEG FILE UNDER WRONG NODE/NAME. FOLLOWING ARE THE DETAILS OF THESE TICKETS: · TICKET# (B)(4) (300149837): ON (B)(6) 2018 CUSTOMER AT (B)(6) MEDICAL CENTER REPORTED ISSUE OF EEG DATA FILED UNDER WRONG NODE ON A/DELL-7040SFF WITH SERIAL# (B)(6). THE ISSUE WAS RESOLVED THE ROOT CAUSE OF THE ISSUE WAS DETERMINED TO BE MULTIPLE UNGARCEFUL SHUTDOWNS; · TICKET# (B)(4) (300128838): ON (B)(6) 2018 CUSTOMER AT (B)(6) HOSPITAL REPORTED ISSUE OF EEG DATA FILED UNDER WRONG PATIENT ON A/DELL-7040SFF WITH SERIAL# (B)(6). THE ISSUE WAS RESOLVED THE ROOT CAUSE OF THE ISSUE WAS DETERMINED TO BE USER ERROR; · TICKET# (B)(4) (300155351): ON (B)(6) 2019 CUSTOMER AT (B)(6) MEDICAL CENTER REPORTED ISSUE OF FILED UNDER WRONG NODE ON A/DELL-7040SFF WITH SERIAL# (B)(6) THE ISSUE WAS RESOLVED THE ROOT CAUSE OF THE ISSUE WAS DETERMINED TO BE USER ERROR ; · TICKET# (B)(4) (300180889): ON (B)(6) 2019 CUSTOMER AT (B)(6) MEDICAL CTR REPORTED ISSUE OF PATIENT RECORDED UNDER WRONG NAME ON A/DELL-7040SFF WITH SERIAL# (B)(6). THE ISSUE WAS RESOLVED THE ROOT CAUSE OF THE ISSUE WAS DETERMINED TO BE USER ERROR ; · TICKET# (B)(4) (300158694): ON (B)(6) 2019 CUSTOMER AT (B)(6) MEDICAL CENTER REPORTED ISSUE OF RECORDED PATIENT UNDER WRONG NODE ON A/DELL-7040SFF WITH SERIAL# (B)(6) THE ISSUE WAS RESOLVED THE ROOT CAUSE OF THE ISSUE WAS DETERMINED TO BE USER ERROR; · TICKET# (B)(4) (300185092): ON (B)(6) 2019 CUSTOMER AT (B)(6) REPORTED ISSUE OF RECORDED STUDY UNDER WRONG PATIENT ON A/DELL-7040SFF WITH SERIAL# (B)(6). THE ISSUE WAS RESOLVED THE ROOT CAUSE OF THE ISSUE WAS DETERMINED TO BE USER ERROR; · TICKET# (B)(4) (300186629): ON (B)(6) 2019 CUSTOMER AT (B)(6) MEDICAL CENTER REPORTED ISSUE OF STUDY IS RECORDER UNDER THE WRONG NAME ON A/DELL-7040SFF WITH SERIAL# (B)(6) THE ISSUE WAS RESOLVED THE ROOT CAUSE OF THE ISSUE WAS DETERMINED TO BE USER ERROR; · TICKET# (B)(6) (300156665): ON (B)(6) 2019 CUSTOMER AT (B)(6) MEDICAL CENTER REPORTED ISSUE OF STUDY RAN UNDER THE WRONG PATIENT NAME ON A/DELL-7040SFF WITH SERIAL# (B)(6) THE ISSUE WAS RESOLVED. THE ROOT CAUSE OF THE ISSUE WAS DETERMINED TO BE USER ERROR ; · TICKET# (B)(6) (300153107): ON (B)(6) 2018 CUSTOMER AT (B)(6) MEDICAL CENTER REPORTED ISSUE OF STUDY UNDER WRONG PATIENT ON A/DELL-7040SFF WITH SERIAL# (B)(6). THE ISSUE WAS RESOLVED. THE ROOT CAUSE OF THE ISSUE WAS DETERMINED TO BE USER ERROR; · TICKET# (B)(6) (300157903): ON (B)(6) 2019 CUSTOMER AT (B)(6) MED CTR REPORTED ISSUE OF STUDY UNDER WRONG PATIENT ON A/DELL-7040SFF WITH SERIAL# (B)(6). THE ISSUE WAS RESOLVED THE ROOT CAUSE OF THE ISSUE WAS DETERMINED TO BE USER ERROR. THE ROOT CAUSES OF 9 THE ABOVE-MENTIONED ISSUES ARE USER ERROR AS CUSTOMER BY MISTAKE SAVE THE FILE UNDER WRONG NODE OR NAME. HOWEVER, 1 OF THE ISSUE WAS CAUSED DUE TO MULTIPLE UNGRACEFUL SHUTDOWN. CORRECTIVE ACTION: AS A CORRECTIVE ACTION, USER NEEDS TO BE EDUCATED BY NKTS ON ASSIGNING CORRECT NODES/NAME TO THE PATIENT WHILE SAVING EEG FILE IN DATABASE. INVESTIGATION RESULT(S): ROOT CAUSE OF THE ISSUE WAS IDENTIFIED TO BE MULTIPLE UNGRACEFUL SHUTDOWNS FROM THE EVENT LOG. REVIEW OF DEVICE SAP HISTORY FOUND NO PREVIOUSLY REPORTED AUDIO ALARM ISSUES WITH THE UNIT. THE WARRANTY OF THE DEVICE EXPIRED ON 09/17/2011. ADDITIONAL INFORMATION: B4. DATE OF THIS REPORT; F6. DATE USER FACILITY/IMPORTER BECAME AWARE OF THE EVENT; F7. TYPE OF REPORT; F11. DATE REPORT SENT TO FDA; F13. DATE REPORT SENT TO MANUFACTURER; G4. DATE RECEIVED BY MANUFACTURER; G7. TYPE OF REPORT; H2. IF FOLLOW-UP, WHAT TYPE? ; ADDITIONAL INFORMATION; H6. EVENT PROBLEM AND EVALUATION CODES; H10. ADDITIONAL MANUFACTURER NARRATIVE.

Description of Event or Problem

THE CUSTOMER REPORTED THAT THE EEG DATA RECORDED UNDER ANOTHER PATIENT'S STUDY NODE. NO PATIENT HARM OR INJURY REPORTED.