ORG-9110A

Additional Manufacturer Narrative

THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE EIGHT TRANSMITTERS WERE DISPLAYING COMMUNICATION LOSS, AND THEY WERE UNABLE TO ADMIT ANY PATIENTS. TECHNICAL SUPPORT (TS) GUIDED THEM THROUGH DETERMINING WHICH MULTIPLE PATIENT RECEIVER (ORG) WAS DOWN. TS HAD THE BME REBOOT THE ORG AND RESEAT THE ETHERNET CABLE. AFTER THIS, THE ISSUE WAS RESOLVED, AND COMMUNICATION WAS RESTORED. THERE WERE NO PATIENTS ON THE EIGHT TRANSMITTERS, BUT NOW THEY COULD BE ADMITTED TO THE UNITS. HOWEVER, THE BME REPORTED THAT THE COMMUNICATION LOSS ISSUE REOCCURRED, AND ROUTINE TROUBLESHOOTING DID NOT RESOLVE THE ISSUE. 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 THE INFORMATION WERE MADE, BUT NOT PROVIDED: D10 ATTEMPT # 1: 07/22/2025 EMAILED THE BME FOR ALL INFORMATION IN THE NI LIST ABOVE: THE BME REPLIED THAT NONE OF THE REQUESTED INFORMATION CAN BE PROVIDED. ADDITIONAL DEVICE INFORMATION: D10 CONCOMITANT MEDICAL DEVICE: THE FOLLOWING DEVICES WERE USED IN CONJUNCTION WITH THE ORG: CNS: MODEL #: NI. SERIAL #: NI. DEVICE MANUFACTURER DATA: NI. UNIQUE IDENTIFIER (UDI) #: NI. RETURNED TO NIHON KOHDEN: NA. ZM TRANSMITTERS: MODEL #: NI. SERIAL #: NI. DEVICE MANUFACTURER DATA: NI. UNIQUE IDENTIFIER (UDI) #: NI. RETURNED TO NIHON KOHDEN: NA.

Description of Event or Problem

THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE MULTIPLE PATIENT RECEIVER (ORG) CAUSED 8 TRANSMITTERS TO DISPLAY COMMUNICATION LOSS. NOT IN PATIENT USE AT THE TIME.

Description of Event or Problem

THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE MULTIPLE PATIENT RECEIVER (ORG) CAUSED 8 TRANSMITTERS TO DISPLAY COMMUNICATION LOSS. NOT IN PATIENT USE AT THE TIME.

Additional Manufacturer Narrative

DETAILS OF COMPLAINT: THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE EIGHT TRANSMITTERS WERE DISPLAYING COMMUNICATION LOSS, AND THEY WERE UNABLE TO ADMIT ANY PATIENTS. TECHNICAL SUPPORT (TS) GUIDED THEM THROUGH DETERMINING WHICH MULTIPLE PATIENT RECEIVER (ORG) WAS DOWN. TS HAD THE BME REBOOT THE ORG AND RESEAT THE ETHERNET CABLE. AFTER THIS, THE ISSUE WAS RESOLVED, AND COMMUNICATION WAS RESTORED. THERE WERE NO PATIENTS ON THE EIGHT TRANSMITTERS, BUT NOW THEY COULD BE ADMITTED TO THE UNITS. HOWEVER, THE BME REPORTED THAT THE COMMUNICATION LOSS ISSUE REOCCURRED, AND ROUTINE TROUBLESHOOTING DID NOT RESOLVE THE ISSUE. INVESTIGATION SUMMARY: THE REPORTED DEVICE ORG-9110A (SN: (B)(6)) WAS RETURNED UNDER TICKET 236958 - 300409003 FOR A SIMILAR COMMUNICATION LOSS ISSUE, WHICH NIHON KOHDEN INVESTIGATED. EVALUATION OF THE RETURNED ORG CONFIRMED THE REPORTED COMMUNICATION LOSS AND FOUND THE ISSUE TO BE REPRODUCIBLE DURING TESTING. TROUBLESHOOTING IDENTIFIED A DEFECTIVE CPU BOARD (UR-3981) AS THE CAUSE, REQUIRING REPLACEMENT. THE ROOT CAUSE WAS DETERMINED TO BE A FAILED CPU BOARD WITHIN THE ORG-9110A, CAUSING COMMUNICATION LOSS. NO FURTHER INVESTIGATION IS REQUIRED. THE FOLLOWING FIELD CONTAINS NO INFORMATION (NI), AS ATTEMPTS TO OBTAIN THE INFORMATION WERE MADE, BUT NOT PROVIDED: D10. ATTEMPT # 1: 07/22/2025 EMAILED THE BME FOR ALL INFORMATION IN THE NI LIST ABOVE: THE BME REPLIED THAT NONE OF THE REQUESTED INFORMATION CAN BE PROVIDED. ADDITIONAL DEVICE INFORMATION: D10 CONCOMITANT MEDICAL DEVICE: THE FOLLOWING DEVICES WERE USED IN CONJUNCTION WITH THE ORG: CNS: MODEL #: NI, SERIAL #: NI, DEVICE MANUFACTURER DATA: NI, UNIQUE IDENTIFIER (UDI) #: NI, RETURNED TO NIHON KOHDEN:NA. ZM TRANSMITTERS: MODEL #: NI, SERIAL #: NI, DEVICE MANUFACTURER DATA: NI, UNIQUE IDENTIFIER (UDI) #: NI, RETURNED TO NIHON KOHDEN: NA. ADDITIONAL INFORMATION: B4 DATE OF THIS REPORT, G3 DATE RECEIVED BY MANUFACTURER, G6 TYPE OF REPORT, H2 IF FOLLOW-UP, WHAT TYPE?, H3 DEVICE EVALUATED BY MANUFACTURER, H6 EVENT PROBLEM AND EVALUATION CODES, H11 ADDITIONAL MANUFACTURER NARRATIVE.