NEUROFAX

Description of Event or Problem

THE EEG TECHNICIAN REPORTED THAT THEY HAD A CAMERA OUTAGE IN THEIR EMU ROOM 2 AT 2:30 AM ON 11/30/2023 AND THE RECORDING CAMERA WINDOW WAS BLACK ON BOTH THE MONITORING TECHNICIAN'S SIDE AND THE ACQUISITION MACHINE. THE EEG TECHNICIAN CLOSED OUT OF THEIR PROGRAM AND WATCHED THE PATIENT. THEY REBOOTED THE EMU ROOM 2 COMPUTER AND WAITED FOR IT TO FULLY LOAD, RESTARTED THE ACQUISITION TO MAKE SURE THEY WERE ABLE TO SEE THE VIDEO DURING ACQUISITION. NO PATIENT HARM WAS REPORTED.

Additional Manufacturer Narrative

THE EEG TECHNICIAN REPORTED THAT THEY HAD A CAMERA OUTAGE IN THEIR EMU ROOM 2 AT 2:30 AM ON 11/30/2023 AND THE RECORDING CAMERA WINDOW WAS BLACK ON BOTH THE MONITORING TECHNICIAN'S SIDE AND THE ACQUISITION MACHINE. THE EEG TECHNICIAN CLOSED OUT OF THEIR PROGRAM AND WATCHED THE PATIENT. THEY REBOOTED THE EMU ROOM 2 COMPUTER AND WAITED FOR IT TO FULLY LOAD, RESTARTED THE ACQUISITION TO MAKE SURE THEY WERE ABLE TO SEE THE VIDEO DURING ACQUISITION. NO PATIENT HARM WAS REPORTED. EEG TECHNICIAN DID NOT PROVIDE THE SERIAL NUMBER OF THE EEG-1200A SYSTEM SO THE MANUFACTURER DATE AND SERIAL NUMBER IS BLANK. 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 TECHNICIAN REPORTED THAT THEY HAD A CAMERA OUTAGE IN THEIR EMU ROOM 2 AT 2:30 AM ON 11/30/2023 AND THE RECORDING CAMERA WINDOW WAS BLACK ON BOTH THE MONITORING TECHNICIAN'S SIDE AND THE ACQUISITION MACHINE. THE EEG TECHNICIAN CLOSED OUT OF THEIR PROGRAM AND WATCHED THE PATIENT. THEY REBOOTED THE EMU ROOM 2 COMPUTER AND WAITED FOR IT TO FULLY LOAD, RESTARTED THE ACQUISITION TO MAKE SURE THEY WERE ABLE TO SEE THE VIDEO DURING ACQUISITION. NO PATIENT HARM WAS REPORTED.

Additional Manufacturer Narrative

DETAILS OF COMPLAINT: THE EEG TECHNICIAN REPORTED THAT THEY HAD A CAMERA OUTAGE IN THEIR EMU ROOM 2 AT 2:30 AM ON (B)(6) 2023 AND THE RECORDING CAMERA WINDOW WAS BLACK ON BOTH THE MONITORING TECHNICIAN'S SIDE AND THE ACQUISITION MACHINE. THE EEG TECHNICIAN CLOSED OUT OF THEIR PROGRAM AND WATCHED THE PATIENT. THEY REBOOTED THE EMU ROOM 2 COMPUTER AND WAITED FOR IT TO FULLY LOAD, RESTARTED THE ACQUISITION TO MAKE SURE THEY WERE ABLE TO SEE THE VIDEO DURING ACQUISITION. NO PATIENT HARM WAS REPORTED. EEG TECHNICIAN DID NOT PROVIDE THE SERIAL NUMBER OF THE EEG-1200A SYSTEM SO THE MANUFACTURER DATE AND SERIAL NUMBER IS BLANK. INVESTIGATION SUMMARY: ROOT CAUSE ANALYSIS: WE DETERMINED THE ROOT CAUSE TO BE POWER RELATED ISSUES. SINCE THE CUSTOMER STATED THE CAMERA EXPERIENCED AN OUTAGE, OUR NES TECHNICIAN RECOMMENDED PERFORMING A GENERATOR TEST. A POWER GENERATOR TEST INCLUDES A SERIES OF EVALUATIONS DESIGNED TO MAKE CERTAIN EACH COMPONENT IS FUNCTIONING OPTIMALLY. TYPICALLY, POWER RELATED ISSUES OCCUR DUE TO POWER OUTAGES AT THE CUSTOMER'S FACILITY OR SUDDEN SURGES IN POWER, HOWEVER, A DEFINITIVE ROOT CAUSE OF THE OUTAGE COULD NOT BE DETERMINED DUE TO LACK OF INFORMATION PROVIDED BY THE CUSTOMER. DEVICE HISTORY REVIEW: 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. WE WILL CONTINUE TO MONITOR TRENDS FOR THIS DEVICE AND FACILITY FOR SIMILAR COMPLAINT ISSUES. THE FOLLOWING FIELDS CONTAIN NO INFORMATION (NI), AS ATTEMPTS TO OBTAIN INFORMATION WERE MADE, BUT NOT PROVIDED: A4 PATIENT WEIGHT ATTEMPT # 1: 12/15/2023 EMAILED THE CUSTOMER VIA MICROSOFT OUTLOOK FOR PATIENT INFORMATION: REPLY WAS RECEIVED AND THE EEG TECHNICIAN PROVIDED THE A2- A6 FIELDS. ADDITIONAL INFORMATION: B4 DATE OF THIS REPORT D4 ADDITIONAL DEVICE INFORMATION/SERIAL NUMBER G3 DATE RECEIVED BY MANUFACTURER G6 TYPE OF REPORT H2 IF FOLLOW-UP, WHAT TYPE? H3 DEVICE EVALUATED BY MANUFACTURER H4 DEVICE MANUFACTURER DATE H6 EVENT PROBLEM AND EVALUATION CODES H11 ADDITIONAL MANUFACTURER NARRATIVE.

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. ADDITIONAL INFORMATION: B4 DATA OF THIS REPORT G6 TYPE OF REPORT H2 IF FOLLOW UP, WHAT TYPE?

Description of Event or Problem

THE EEG TECHNICIAN REPORTED THAT THEY HAD A CAMERA OUTAGE IN THEIR EMU ROOM 2 AT 2:30 AM ON (B)(6) 2023 AND THE RECORDING CAMERA WINDOW WAS BLACK ON BOTH THE MONITORING TECHNICIAN'S SIDE AND THE ACQUISITION MACHINE. THE EEG TECHNICIAN CLOSED OUT OF THEIR PROGRAM AND WATCHED THE PATIENT. THEY REBOOTED THE EMU ROOM 2 COMPUTER AND WAITED FOR IT TO FULLY LOAD, RESTARTED THE ACQUISITION TO MAKE SURE THEY WERE ABLE TO SEE THE VIDEO DURING ACQUISITION. NO PATIENT HARM WAS REPORTED.