NEUROFAX

Description of Event or Problem

THE CUSTOMER REPORTED THAT THE EVENT MARKER ALARMS FEATURE E12NOTIFY AND ANNOT WOULD RANDOMLY STOP ALARMING VISUALLY AND AUDIBLY FOR THE EEG1200A SYSTEMS. NO PATIENT HARM WAS REPORTED.

Additional Manufacturer Narrative

DETAILS OF COMPLAINT: THE CUSTOMER REPORTED THAT THE EVENT MARKER ALARMS FEATURE E12NOTIFY AND ANNOT WOULD RANDOMLY STOP ALARMING VISUALLY AND AUDIBLY FOR THE EEG1200A SYSTEMS. THE WORK AROUND WAS RESTARTING THE STUDY EVERY COUPLE OF HOURS TO KEEP THE BUTTON WORKING. NO PATIENT HARM WAS REPORTED. INVESTIGATION SUMMARY: ON 12/01/2023, TS FOLLOWED UP WITH THE CUSTOMER AND DISCOVERED THAT THE SYSTEM WAS WORKING WELL BUT STOPPED WORKING AFTER THE SIXTH HOUR. AFTER TROUBLESHOOTING, IT WAS SUSPECTED THAT THE CUSTOMER'S ANTIVIRUS MAY HAVE BLOCKED THE EXECUTABLES FOR E12NOTIFY AND ANNOTATION. TS GATHERED LOGS FOR ALL THREE MACHINES AND DISCUSSED THEM WITH THE CUSTOMER, WHO SUGGESTED THAT THE ISSUE MAY BE RELATED TO SHIFT CHANGES AND THE CHECKING OF SYSTEM MARK BUTTONS. OUR NEUROLOGY ENGINEERING SERVICES (NES) TECHNICIAN OFFERED TO REMOTELY INVESTIGATE THE ISSUE, BUT THE CUSTOMER ASKED IF UPGRADING DRIVERS WOULD HELP. THE NES TECHNICIAN RECOMMENDED UPGRADING THE DRIVERS BUT WAS UNSURE IF THIS WAS THE CAUSE OF THE ISSUE. AFTER THREE ATTEMPTS TO FOLLOW UP WITH THE CUSTOMER, THERE WAS NO RESPONSE, AND IT IS UNCLEAR WHETHER THE ISSUE WAS RESOLVED. WE WERE UNABLE TO DETERMINE A ROOT CAUSE. A POSSIBLE ROOT CAUSE MAY BE ATTRIBUTED TO ANTIVIRUS ISSUES. TYPICALLY, THESE ISSUES OCCUR DUE TO THE ANTIVIRUS BLOCKING CERTAIN IMPORTANT FILES OR PROGRAMS. NIHON KOHDEN DOES NOT MANAGE EXCLUSIONS, AND CUSTOMERS MUST SET THE APPROPRIATE EXCLUSIONS TO AVOID INTERFERING WITH NIHON KOHDEN PRODUCTS. OUR NES TECHNICIAN FOLLOWED UP WITH THE CUSTOMER ON MULTIPLE OCCASIONS TO OFFER GUIDANCE, BUT THE CUSTOMER DID NOT RESPOND. ALTHOUGH THERE WAS PATIENT INVOLVEMENT, THERE WAS NO INJURY, NO HARM, NOR ANY ADVERSE EVENT DUE TO THE REPORTED ISSUE. DURING THE REVIEW OF THE DEVICE HISTORY FOR THE REPORTED ISSUE, IT WAS DISCOVERED THIS DEVICE WAS INSTALLED ON (B)(6) 2020. WE FOUND THREE SIMILAR ISSUES FOR SIMILAR DEVICES (PRODUCT ID: A/DELL-7050SFF-W10) WITH SEPARATE SERIAL NUMBERS THAT OCCURRED AT THIS FACILITY AROUND THE SAME TIME FRAME. THESE SIMILAR COMPLAINTS WERE DISCOVERED OVER THE PAST FOUR YEARS AND ARE AS FOLLOWS: TICKET#: (B)(4) (REPORTED ON (B)(6) 2023 FOR SERIAL NUMBER: (B)(6), TICKET#: (B)(4) (REPORTED ON (B)(6) 2023 FOR SERIAL NUMBER: (B)(6), AND TICKET#: (B)(4) (REPORTED ON (B)(6) 2023 FOR SERIAL NUMBER: (B)(6). A REVIEW OF HISTORICAL DATA DOES NOT REVEAL A SIGNIFICANT TREND THAT WOULD CONTRIBUTE TO COMPONENT FAILURE THAT IS RELATED TO THE DESIGN OR MANUFACTURING OF THE DEVICE. MOREOVER, SINCE 11/30/2023, NO FURTHER SIMILAR ISSUES HAVE BEEN REPORTED BY THIS FACILITY FOR THIS DEVICE. WE WILL CONTINUE TO MONITOR TRENDS FOR THIS DEVICE AND FACILITY FOR SIMILAR COMPLAINT ISSUES. ATTEMPT # 2: 11/27/2023 EMAILED THE CUSTOMER FOR THE PATIENT INFORMATION: THE CUSTOMER RESPONDED WITH AS MUCH PATIENT INFORMATION THAT THEY COULD. 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 EVENT MARKER ALARMS FEATURE E12NOTIFY AND ANNOT WOULD RANDOMLY STOP ALARMING VISUALLY AND AUDIBLY FOR THE EEG1200A SYSTEMS. NO PATIENT HARM WAS REPORTED.

Additional Manufacturer Narrative

THE CUSTOMER REPORTED THAT THE EVENT MARKER ALARMS FEATURE E12NOTIFY AND ANNOT WOULD RANDOMLY STOP ALARMING VISUALLY AND AUDIBLY FOR THE EEG1200A SYSTEMS. THE WORKAROUND WAS RESTARTING THE STUDY EVERY COUPLE OF HOURS TO KEEP THE BUTTON WORKING. 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 FIELDS CONTAIN NO INFORMATION (NI), AS ATTEMPTS TO OBTAIN INFORMATION WERE MADE, BUT NOT PROVIDED: A4, A6 B7 ATTEMPT # 1: 11/20/2023 EMAILED THE CUSTOMER FOR THE PATIENT INFORMATION: NO REPLY WAS RECEIVED. ATTEMPT # 2: 11/27/2023 EMAILED THE CUSTOMER FOR THE PATIENT INFORMATION: THE CUSTOMER RESPONDED WITH AS MUCH PATIENT INFORMATION THAT THEY COULD.

Description of Event or Problem

THE CUSTOMER REPORTED THAT THE EVENT MARKER ALARMS FEATURE E12NOTIFY AND ANNOT WOULD RANDOMLY STOP ALARMING VISUALLY AND AUDIBLY FOR THE EEG1200A SYSTEMS. NO PATIENT HARM WAS REPORTED.

Additional Manufacturer Narrative

UDI RELATED DATA QUALITY UPDATES. CORRECTED INFORMATION: D1 BRAND NAME: CORRECTED THE BRAND NAME FROM EEG-1200A TO NEUROFAX. D4 ADDITIONAL DEVICE INFORMATION / PRIMARY UNIQUE DEVICE IDENTIFIER (UDI) #: CORRECTED THE UDI # TO INCLUDE THE PRODUCTION IDENTIFIER (PI) INFORMATION. THIS IS A CORRECTION TO THE SUSPECT MEDICAL DEVICE INVOLVED IN THE REPORTED EVENT, SPECIFICALLY THE UNIQUE DEVICE IDENTIFIER (UDI) INFORMATION IN SECTION D OF THE FDA FORM 3500A.