EEG-1200A
Received Dec 4, 2018 · Event occurred Nov 6, 2018
Report 8030229-2018-00461 · MDR key 8131035
Device
Generic name
Neurofax Electroencephalograph
Manufacturer
Nihon Kohden CorporationModel number
EEG-1200ACatalog number
EEG-1200A
Lot number
NOT APPLICABLE
Product problems
- Appropriate Device Problem Term/Code Not Available
- Appropriate Device Problem Term/Code Not Available
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
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
H10: ADDITIONAL NARRATIVE: THE CUSTOMER REPORTED THAT THEIR SYSTEM IS RECORDING UNDER INCORRECT NAME. SERVICE REQUESTED: TROUBLESHOOTING. SERVICE PROVIDED: TROUBLESHOOTING. INVESTIGATION RESULT: THE LAST TWO STUDIES STARTED ON CUSTOMER'S UNIT WERE SAVED UNDER ONE NAME. THE ISSUE WAS RESOLVED BY TS, STARTING A NEW DATA SCHEDULE WITH THE CORRECT PATIENT INFORMATION, NOTED THE DB KEY AND CHANGED THE NODES THAT WERE INCORRECTLY FILED UNDER THE WRONG PATIENT INFORMATION. THE ROOT CAUSE OF THE ISSUE WAS UNABLE TO BE DETERMINED. A REVIEW OF DEVICE HISTORY FOUND NO PREVIOUSLY REPORTED ISSUE WITH THIS UNIT. THE CUSTOMER'S ISSUE WAS RESOLVED AND NO SIMILAR ISSUE WAS REPORTED SUBSEQUENT TO THE RESOLUTION. THE ROOT CAUSE OF THE ISSUE COULD NOT BE DETERMINED. QE INVESTIGATION FOR THE COMPLAINT RECORD HAS BEEN COMPLETED. CORRECTED INFORMATION: G4. DATE RECEIVED BY MANUFACTURER: SHOULD BE 11/06/2018 NOT 12/04/2018 AS LISTED ON MDR INITIAL REPORT. ADDITIONAL INFORMATION: B4. DATE OF THIS REPORT; E1. INITIAL REPORTER EMAIL; 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 CORRECTION; H3. DEVICE EVALUATED BY MANUFACTURER? ; H6. EVENT PROBLEM AND EVALUATION CODES; H10. ADDITIONAL MANUFACTURER NARRATIVE. THE FOLLOWING FIELDS DO NOT CONTAIN INFORMATION AS THIS UNIT IS NOT SERIALIZED. THEREFORE, THE FOLLOWING FIELDS DO NOT CONTAIN INFORMATION. D4. SERIAL #. F9. APPROXIMATE AGE OF DEVICE. H4. DEVICE MANUFACTURE DATE.
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.