ORG-9110A

Additional Manufacturer Narrative

THE IT DEPARTMENT REPORTED THAT THE CENTRAL NURSE'S STATION (CNS) DISPLAYED "COMMUNICATION LOSS" FOR ALL TELEMETRY DEVICES ON THIS MULTIPLE PATIENT RECEIVER (ORG) AND IT WAS UNABLE TO MONITOR THE PATIENTS. IT ALSO HAD A LIT ERROR LIGHT. REBOOTING THE ORG AND LEAVING IT OFF FOR 5 MINUTES DID NOT RESOLVE THE ISSUE. 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.

Description of Event or Problem

THE IT DEPARTMENT REPORTED THAT THE CENTRAL NURSE'S STATION (CNS) DISPLAYED "COMMUNICATION LOSS" FOR ALL TELEMETRY DEVICES ON THIS MULTIPLE PATIENT RECEIVER (ORG) AND IT WAS UNABLE TO MONITOR THE PATIENTS. IT ALSO HAD A LIT ERROR LIGHT. NO PATIENT HARM WAS REPORTED.

Description of Event or Problem

THE IT DEPARTMENT REPORTED THAT THE CENTRAL NURSE'S STATION (CNS) DISPLAYED "COMMUNICATION LOSS" FOR ALL TELEMETRY DEVICES ON THIS MULTIPLE PATIENT RECEIVER (ORG) AND IT WAS UNABLE TO MONITOR THE PATIENTS. IT ALSO HAD A LIT ERROR LIGHT. NO PATIENT HARM WAS REPORTED.

Additional Manufacturer Narrative

DETAILS OF COMPLAINT: THE IT DEPARTMENT REPORTED THAT THE CENTRAL NURSE'S STATION (CNS) DISPLAYED "COMMUNICATION LOSS" FOR ALL TELEMETRY DEVICES ON THIS MULTIPLE PATIENT RECEIVER (ORG) AND IT WAS UNABLE TO MONITOR THE PATIENTS. IT ALSO HAD A LIT ERROR LIGHT. REBOOTING THE ORG AND LEAVING IT OFF FOR 5 MINUTES DID NOT RESOLVE THE ISSUE. NO PATIENT HARM WAS REPORTED. INVESTIGATION SUMMARY: THE DEVICE WAS SENT TO NKA FOR EVALUATION AND REPAIR. THE REPORTED ERROR LIGHT WAS DUPLICATED, AND THE CAUSE WAS DETERMINED TO BE A MALFUNCTION OF THE UR-3981 CPU BOARD. THE COMPONENT WAS REPLACED, AND THE UNIT PERFORMED TO MANUFACTURER'S SPECIFICATIONS. A REVIEW OF THE DEVICE'S COMPLAINT HISTORY BY SERIAL NUMBER REVEALS NO SIMILAR ISSUES. 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 ATTEMPT # 1: 01/05/2026 EMAILED THE CUSTOMER VIA MICROSOFT OUTLOOK FOR THE INFORMATION IN THE NI LIST ABOVE: NO REPLY WAS RECEIVED. ATTEMPT # 2: 01/12/2026 EMAILED THE CUSTOMER VIA MICROSOFT OUTLOOK FOR THE INFORMATION IN THE NI LIST ABOVE: THE CUSTOMER REPLIED, BUT ONLY ASKED A QUESTION. ATTEMPT # 3: 01/12/2026 EMAILED THE CUSTOMER VIA MICROSOFT OUTLOOK FOR THE INFORMATION IN THE NI LIST ABOVE: THE CUSTOMER REPLIED, BUT DID NOT RESPOND TO MY QUESTION ONCE AGAIN. 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.