ORG-9110A

Description of Event or Problem

THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THEY NOTICED INTERMITTENT COMMUNICATION LOSS ON THE ZM TELEMETRY UNIT. THE MULTIPLE PATIENT RECEIVER (ORG) DISPLAYED A CONSTANT ERROR LIGHT BLINKING DESPITE REBOOTING AND REPLACING THE ETHERNET CABLE. NO PATIENT HARM WAS REPORTED.

Additional Manufacturer Narrative

THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THEY NOTICED INTERMITTENT COMMUNICATION LOSS ON THE ZM TELEMETRY UNIT. THE MULTIPLE PATIENT RECEIVER (ORG) DISPLAYED A CONSTANT ERROR LIGHT BLINKING DESPITE REBOOTING AND REPLACING THE ETHERNET CABLE. THE BME BEGAN TESTING THE ADDITIONAL ZMS THAT WERE PAUSED AND THEY ALSO WENT INTO COMM LOSS. THE COMM LOSS PERSISTED WITH THE TRANSMITTERS CONNECTED TO THIS ORG. 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 THE INFORMATION WERE MADE, BUT NOT PROVIDED: ATTEMPT # 1: 01/15/2026 - EMAILED THE BME FOR THE OTHER 7 TRANSMITTERS IN THE NI LIST ABOVE: NO REPLY WAS RECEIVED. ATTEMPT # 2: 01/20/2026 - EMAILED THE BME FOR THE OTHER 7 TRANSMITTERS IN THE NI LIST ABOVE: NO REPLY WAS RECEIVED. ATTEMPT # 3: 01/26/2026 - EMAILED THE BME FOR THE OTHER 7 TRANSMITTERS IN THE NI LIST ABOVE: NO REPLY WAS RECEIVED. ADDITIONAL DEVICE INFORMATION: D10 CONCOMITANT MEDICAL DEVICE: THE FOLLOWING DEVICES WERE USED IN CONJUNCTION WITH THE ORG: CNS - MODEL #: CNS-2101, SERIAL #: (B)(6), DEVICE MANUFACTURER DATA: 03/22/2024, UNIQUE IDENTIFIER (UDI) #: (B)(4), RETURNED TO NIHON KOHDEN: NA. ZM TRANSMITTER - MODEL #: ZM-531PA, SERIAL #: (B)(6), DEVICE MANUFACTURER DATA: NI, UNIQUE IDENTIFIER (UDI) #: (B)(4), 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 Manufacturer Narrative

DETAILS OF COMPLAINT: THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THEY NOTICED INTERMITTENT COMMUNICATION LOSS ON THE ZM TELEMETRY UNIT. THE MULTIPLE PATIENT RECEIVER (ORG) DISPLAYED A CONSTANT ERROR LIGHT BLINKING DESPITE REBOOTING AND REPLACING THE ETHERNET CABLE. THE BME BEGAN TESTING THE ADDITIONAL ZMS THAT WERE PAUSED AND THEY ALSO WENT INTO COMM LOSS. THE COMM LOSS PERSISTED WITH THE TRANSMITTERS CONNECTED TO THIS ORG. NO PATIENT HARM WAS REPORTED. INVESTIGATION SUMMARY: THE COMPLAINT DEVICE WAS RETURNED TO NIHON KOHDEN FOR EVALUATION AND REPAIR. DURING EVALUATION, THE REPORTED ISSUE WAS DUPLICATED, AND THE CAUSE OF THE COMPLAINT WAS DETERMINED TO BE FAULT IN THE UR-3981 CPU BOARD. AFTER THE MALFUNCTIONING COMPONENT WAS REPLACED, THE DEVICE PERFORMED TO MANUFACTURER'S SPECIFICATIONS. A REVIEW OF THE DEVICE'S COMPLAINT HISTORY BY SERIAL NUMBER REVEALS NO SIMILAR ISSUES. THE DEVICE HAD BEEN INSTALLED AT THE CUSTOMER FACILITY SINCE APRIL 2015, SO THE HARDWARE FAILURE WAS LIKELY RELATED TO ACCUMULATED WEAR-AND-TEAR. A SIGNIFICANT TREND HAS NOT BEEN OBSERVED THAT WOULD WARRANT ANY FURTHER CORRECTIVE ACTION. NIHON KOHDEN WILL CONTINUE TO TREND AND MONITOR. THE FOLLOWING FIELD CONTAINS NO INFORMATION (NI), AS ATTEMPTS TO OBTAIN THE INFORMATION WERE MADE, BUT NOT PROVIDED: D10. ADDITIONAL DEVICE INFORMATION: D10 CONCOMITANT MEDICAL DEVICE: THE FOLLOWING DEVICES WERE USED IN CONJUNCTION WITH THE ORG: CNS MODEL #: CNS-2101, SERIAL #: (B)(6), DEVICE MANUFACTURER DATA: 03/22/2024, UNIQUE IDENTIFIER (UDI) #: (B)(4), RETURNED TO NIHON KOHDEN: NA. ZM TRANSMITTER: MODEL #: ZM-531PA, SERIAL #: (B)(6), DEVICE MANUFACTURER DATA: NI, UNIQUE IDENTIFIER (UDI) #: (B)(4), 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.

Description of Event or Problem

THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THEY NOTICED INTERMITTENT COMMUNICATION LOSS ON THE ZM TELEMETRY UNIT. THE MULTIPLE PATIENT RECEIVER (ORG) DISPLAYED A CONSTANT ERROR LIGHT BLINKING DESPITE REBOOTING AND REPLACING THE ETHERNET CABLE. NO PATIENT HARM WAS REPORTED.