NEUROFAX

Additional Manufacturer Narrative

THE CUSTOMER REPORTED THAT THE EEG SYSTEM HAD CRASHED DURING A PHASE 2 EEG EXAM, AND THEY NEEDED HELP RETRIEVING THE PATIENT'S CUSTOM PROTOCOL. NO PATIENT HARM WAS 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. THE FOLLOWING FIELD CONTAINS NO INFORMATION (NI), AS ATTEMPTS TO OBTAIN MORE INFORMATION WERE MADE, BUT NOT PROVIDED: ADDITIONAL DEVICE INFORMATION: D10 CONCOMITANT MEDICAL DEVICE: THE FOLLOWING DEVICE WAS USED IN CONJUNCTION WITH THE EEG-1200A SYSTEM: DEVICE TYPE: DELL PC, MODEL#: A/DELL-9020SFF, SERIAL#: (B)(6), DEVICE MANUFACTURER DATA: 03/29/2017, UNIQUE IDENTIFIER (UDI) #: NA, RETURNED TO NIHON KOHDEN: NOT RETURNED.

Description of Event or Problem

THE CUSTOMER REPORTED THAT THE EEG SYSTEM HAD CRASHED DURING A PHASE 2 EEG EXAM, AND THEY NEEDED HELP RETRIEVING THE PATIENT'S CUSTOM PROTOCOL. NO PATIENT HARM WAS REPORTED.

Additional Manufacturer Narrative

DETAILS OF COMPLAINT: THE CUSTOMER REPORTED THAT THE EEG SYSTEM HAD CRASHED DURING A PHASE 2 EEG EXAM, AND THEY NEEDED HELP RETRIEVING THE PATIENT'S CUSTOM PROTOCOL. NO PATIENT HARM WAS REPORTED. INVESTIGATION SUMMARY: A DEFINITIVE ROOT CAUSE OF HOW OR WHY THE REPORTED INCIDENT OF THE SYSTEM "CRASHED" WAS NOT DETERMINED. BASED ON THE AVAILABLE INFORMATION, THE MOST LIKELY CAUSES COULD BE FROM POWER ISSUES AT THE FACILITY (SUCH AS A POWER SURGE OR POWER OUTAGE) AND/OR USER ERRORS (SUCH AS UNGRACEFUL EXITS), WHICH CAN CAUSE CORRUPTION AND CAUSE SETTINGS/PROTOCOLS TO REVERT AND/OR BECOME MISSING. OR WEAR AND TEAR / DAMAGE ISSUES: IN THIS CASE, THE SYSTEM WAS INITIALLY INSTALLED ON 04/29/2017, INDICATING THE SYSTEM HAS AGED APPROXIMATELY TEN YEARS. THE SYSTEM IS ALSO NO LONGER UNDER WARRANTY. AGING DEVICES AND THEIR SENSITIVE COMPONENTS ARE SUSCEPTIBLE TO WEAR AND TEAR DAMAGE OVER TIME. WEAR AND TEAR DAMAGE TO THE DEVICE AND ITS SENSITIVE HDD (HARD DISK DRIVE) COMPONENTS MAY RESULT IN THE SYSTEM "CRASHING" OR SHUTTING DOWN UNEXPECTEDLY. USER ERRORS (SUCH AS AN UNGRACEFUL EXIT, DROPPAGE RESULTING IN PHYSICAL DAMAGE) IN CONJUNCTION WITH NORMAL AGING AND DEGRADATION CAN CAUSE DAMAGE TO SENSITIVE HDD COMPONENTS. THE PC (PERSONAL COMPUTER) USED WITH THIS SYSTEM WAS SUNSET, AND THE CUSTOMER WAS ALSO INFORMED THAT A REPLACEMENT IS NEEDED. THERE WERE FOUR ISSUES REPORTED FOR THIS SYSTEM, AT THIS FACILITY FOR THE SAME PC USED WITH SIMILAR SYSTEMS, OVER A TWO-YEAR PERIOD. TRENDING FOR SIMILAR ISSUES AND DEVICES WILL CONTINUE TO BE MONITORED. ADDITIONAL DEVICE INFORMATION: D10 CONCOMITANT MEDICAL DEVICE: THE FOLLOWING DEVICE WAS USED IN CONJUNCTION WITH THE EEG-1200A SYSTEM: DEVICE TYPE: DELL PC MODEL #: A/DELL-9020SFF, SERIAL #:(B)(6) DEVICE MANUFACTURER DATA: 03/29/2017 UNIQUE IDENTIFIER (UDI) #: NA RETURNED TO NIHON KOHDEN: NOT RETURNED. 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. H11 ADDITIONAL MANUFACTURER NARRATIVE.

Description of Event or Problem

THE CUSTOMER REPORTED THAT THE EEG SYSTEM HAD CRASHED DURING A PHASE 2 EEG EXAM, AND THEY NEEDED HELP RETRIEVING THE PATIENT'S CUSTOM PROTOCOL. NO PATIENT HARM WAS REPORTED.