EEG-1200A

Description of Event or Problem

THE AMBULATORY CARE CLINICAL MANAGER REPORTED THAT THE CAMERA AND APPLICATION FREEZES CAUSING DATA AND VIDEO LOSS IN EMU ROOM 5. THERE IS AN ERROR MESSAGE THAT APPEARS WHEN THIS HAPPENS. THEY HAVE TO DO MULTIPLE SHUTDOWNS IN ORDER TO HAVE THE RECORDING TO BE STARTED BACK UP. NO PATIENT HARM WAS REPORTED.

Additional Manufacturer Narrative

THE AMBULATORY CARE CLINICAL MANAGER REPORTED THAT THE CAMERA AND APPLICATION FREEZES CAUSING DATA AND VIDEO LOSS IN EMU ROOM 5. THERE IS AN ERROR MESSAGE THAT APPEARS WHEN THIS HAPPENS. THEY HAVE TO DO MULTIPLE SHUTDOWNS IN ORDER TO HAVE THE RECORDING TO BE STARTED BACK UP. 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 ARE NOT APPLICABLE (NA) TO THE MDR REPORT: A6 B2 D4 LOT NUMBER & EXPIRATION D6A - D6B D7B F1 - F14 G4 DEVICE BLA NUMBER G5 G7 H2 H7 H9 THE FOLLOWING FIELDS CONTAINS NO INFORMATION (NI), AS ATTEMPTS TO OBTAIN INFORMATION WERE MADE, BUT SOME OF THE INFORMATION WAS NOT PROVIDED. A4 B6 - B7 D10 CONCOMITANT MEDICAL DEVICE ELECTRODE JUNCTION BOX MODEL: JE-921A SN: (B)(6). DEVICE MANUFACTURER DATE: NI UNIQUE IDENTIFIER (UDI) #: (B)(4).

Additional Manufacturer Narrative

DETAILS OF COMPLAINT: THE AMBULATORY CARE CLINICAL MANAGER REPORTED THAT THE CAMERA AND APPLICATION FOR THE EEG SYSTEM WAS FREEZING, CAUSING DATA AND VIDEO LOSS IN EMU ROOM 5. AN ERROR MESSAGE DISPLAYED WHEN THIS HAPPENED. MULTIPLE SYSTEM SHUTDOWNS WERE PERFORMED WHILE IN PATIENT USE TO GET THE RECORDING TO START AGAIN. NO PATIENT HARM WAS REPORTED. INVESTIGATION SUMMARY: ON (B)(6) 2023, THE CUSTOMER CONTACTED NIHON KOHDEN'S (NK) NEUROLOGY ENGINEERING SERVICES (NES) TECHNICIAN, STATING THE ISSUE WAS STILL OCCURRING. ON (B)(6) 2024, NES STATED THAT THEY FOUND A PROBLEM WITH THE PHYSICAL MEMORY STICK, AND THEY HAD ORDERED A REPLACEMENT. NO FURTHER INFORMATION COULD BE OBTAINED REGARDING THE RESOLUTION OF THE ISSUE. NK DETERMINED THE ROOT CAUSE TO BE POWER RELATED ISSUES. SINCE THE CUSTOMER STATED THE CAMERA EXPERIENCED AN OUTAGE, THE 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. DURING A REVIEW OF THE DEVICE HISTORY FOR THE REPORTED ISSUE, THREE SIMILAR ISSUES WERE FOUND, FOR SIMILAR DEVICES (PRODUCT ID: A/DELL-XE3), WITH SIMILAR SEPARATE SERIAL NUMBERS THAT OCCURRED AT THIS FACILITY AROUND THE SAME TIME FRAME. THESE SIMILAR COMPLAINTS WERE DISCOVERED OVER THE PAST YEAR AND ARE AS FOLLOWS: TICKET #(B)(4) (REPORTED ON 11/30/2023 SN: (B)(6), TICKET #(B)(4) (REPORTED ON 11/30/2023 SN: (B)(6) AND TICKET #(B)(4) (REPORTED ON 12/12/2023 SN: (B)(6). A REVIEW OF THE DEVICE HISTORY DOES NOT REVEAL A SIGNIFICANT TREND THAT WOULD CONTRIBUTE TO COMPONENT FAILURE THAT IS RELATED TO THE DESIGN OR MANUFACTURING OF THE DEVICE. NK WILL CONTINUE TO MONITOR TRENDS FOR THIS DEVICE AND FACILITY FOR SIMILAR COMPLAINT ISSUES. THE FOLLOWING FIELDS CONTAINS NO INFORMATION (NI), AS AN AATTEMPT TO OBTAIN THE INFORMATION WAS MADE, BUT SOME OF THE INFORMATION WAS NOT PROVIDED. ATTEMPT #1 12/05/2023 EMAILED CUSTOMER VIA MICROSOFT OUTLOOK FOR ALL ITEMS UNDER THE NO INFORMATION SECTION. THE CUSTOMER RESPONDED WITH MOST OF THE PATIENT INFORMATION AND SOME OF THE ADDITIONAL DEVICE INFORMATION. ADDITIONAL DEVICE INFORMATION: D10 CONCOMITANT MEDICAL DEVICE: THE FOLLOWING DEVICE WAS USED IN CONJUNCTION WITH THE EEG SYSTEM: ELECTRODE JUNCTION BOX: MODEL: JE-921A. SN: NI. DEVICE MANUFACTURER DATE: NI. UNIQUE IDENTIFIER (UDI) #: (B)(4). 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 AMBULATORY CARE CLINICAL MANAGER REPORTED THAT THE CAMERA AND APPLICATION FOR THE EEG SYSTEM WAS FREEZING, CAUSING DATA AND VIDEO LOSS IN EMU ROOM 5. AN ERROR MESSAGE DISPLAYED WHEN THIS HAPPENED. MULTIPLE SYSTEM SHUTDOWNS WERE PERFORMED WHILE IN PATIENT USE TO GET THE RECORDING TO START AGAIN. NO PATIENT HARM WAS REPORTED.