EEG-1200A
Received Nov 2, 2020 · Event occurred Oct 3, 2020
Report 8030229-2020-00653 · MDR key 10776084
Device
Generic name
Neurofax Electroencephalograph
Manufacturer
Nihon Kohden CorporationModel number
EEG-1200ACatalog number
EEG-1200A
Lot number
NA
Product problems
- Application Program Problem
- Output Problem
- Application Program Problem
- Output Problem
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
DETAILS OF COMPLAINT: THE EEG TECHNICIAN REPORTED THAT THE PATIENT'S NAME ON THE LTM STUDY HAD CHANGED. IT IS UNCLEAR IF SOMEONE ACCIDENTALLY CHANGED THE NAME OR NOT. NIHON KOHDEN TECHNICAL SUPPORT (NK TS) ASSISTED IN CHANGING THE PATIENT INFORMATION. NO HARM OR INJURY WAS REPORTED. INVESTIGATION SUMMARY: THE ALLEGATION OF THE PATIENT'S NAME CHANGING ON ITS OWN COULD NOT BE CONFIRMED. IT IS MORE COMMON THAT THE USER SELECTED THE INCORRECT NAME AT THE START OF THE EXAM. PATIENT INFORMATION ISSUES ARE EASILY RESOLVED BY EDITING THE INFORMATION FOR THE FILES IN QUESTION. THERE HAVE BEEN NO ADDITIONAL COMPLAINTS REPORTING OF AUTOMATIC PATIENT NAME CHANGES AFTER RECORDING. THE ROOT CAUSE IS LIKELY USE ERROR. ADDITIONAL INFORMATION: B4 DATE OF THIS REPORT G3 DATE RECEIVED BY MANUFACTURER G6 TYPE OF REPORT H2 IF FOLLOW-UP, WHAT TYPE? H6 EVENT PROBLEM AND EVALUATION CODES H10 ADDITIONAL MANUFACTURER NARRATIVE.
Description of Event or Problem
THE EEG REPORTED THAT THE PATIENT NAME ON THE LTM STUDY HAD CHANGED. THEY HAD STARTED THE STUDY AND WHEN THEY FINISHED RECORDING THERE WAS A DIFFERENT PATIENT NAME. IT IS UNCLEAR IF SOMEONE ACCIDENTALLY CHANGED THE NAME OR NOT. THEY ARE NOT SURE HOW THIS HAPPENED. NIHON KOHDEN TECHNICAL SUPPORT (TECH SUPPORT) ASSISTED IN CHANGING THE PATIENT INFORMATION. NO PATIENT HARM REPORTED.
Additional Manufacturer Narrative
THE EEG REPORTED THAT THE PATIENT NAME ON THE (B)(6) STUDY HAD CHANGED. THEY HAD STARTED THE STUDY AND WHEN THEY FINISHED RECORDING THERE WAS A DIFFERENT PATIENT NAME. IT IS UNCLEAR IF SOMEONE ACCIDENTALLY CHANGED THE NAME OR NOT. THEY ARE NOT SURE HOW THIS HAPPENED. NIHON KOHDEN TECHNICAL SUPPORT (TECH SUPPORT) ASSISTED IN CHANGING THE PATIENT INFORMATION. NO PATIENT HARM REPORTED. 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.
Description of Event or Problem
THE EEG REPORTED THAT THE PATIENT NAME ON THE (B)(6) STUDY HAD CHANGED. THEY HAD STARTED THE STUDY AND WHEN THEY FINISHED RECORDING THERE WAS A DIFFERENT PATIENT NAME. IT IS UNCLEAR IF SOMEONE ACCIDENTALLY CHANGED THE NAME OR NOT. THEY ARE NOT SURE HOW THIS HAPPENED. NIHON KOHDEN TECHNICAL SUPPORT (TECH SUPPORT) ASSISTED IN CHANGING THE PATIENT INFORMATION. NO PATIENT HARM REPORTED.