ORG-9110A

Description of Event or Problem

THE CUSTOMER REPORTED THAT THE HEART RATE (HR) WAS NOT DISPLAYED ON THE CENTRAL NURSE STATION (CNS), ALTHOUGH IT WAS DISPLAYED ON THE TELEMETRY (TELE) UNIT. THEY HAD ALREADY REBOOTED THE CNS AND TELE. TECHNICAL SUPPORT (TS) HAD THE CUSTOMER REBOOT THE MULTIPLE PATIENT RECEIVER (ORG), BUT THE ISSUE PERSISTED. NO PATIENT HARM WAS REPORTED.

Additional Manufacturer Narrative

THE CUSTOMER REPORTED THAT THE HEART RATE (HR) WAS NOT DISPLAYED ON THE CENTRAL NURSE STATION (CNS), ALTHOUGH IT WAS DISPLAYED ON THE TELEMETRY (TELE) UNIT. THEY HAD ALREADY REBOOTED THE CNS AND TELE. TECHNICAL SUPPORT (TS) HAD THE CUSTOMER REBOOT THE MULTIPLE PATIENT RECEIVER (ORG), BUT THE ISSUE PERSISTED. THEN POWERED DOWN THE ORG FOR APPROXIMATELY THREE MINUTES AND RESTARTED IT, BUT THE ISSUE REMAINED. DURING TROUBLESHOOTING, THEY MOVED THE TELE TO A DIFFERENT RECEIVER CARD AND THE HR DISPLAYED CORRECTLY ON THE CNS. HOWEVER, AFTER MOVING THE TELE BACK TO THE ORIGINAL RECEIVER CARD, THE HR STOPPED DISPLAYING AGAIN. THERE WAS NO PATIENT ASSIGNED TO THE TELE UNIT, AND ALL TESTING WAS PERFORMED USING A SIMULATOR. 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:D10 ATTEMPT # 1:07/01/2026 EMAILED THE BME FOR ALL INFORMATION IN THE NI LIST ABOVE: NO REPLY WAS RECEIVED.ATTEMPT # 2:07/13/2026 EMAILED THE BME FOR ALL INFORMATION IN THE NI LIST ABOVE: NO REPLY WAS RECEIVED.ATTEMPT # 3:07/15/2026 EMAILED THE BME FOR ALL INFORMATION IN THE NI LIST ABOVE: NO REPLY WAS RECEIVED.ADDITIONAL DEVICE INFORMATION: D10 CONCOMITANT MEDICAL DEVICE: THE FOLLOWING DEVICE WERE USED IN CONJUNCTION WITH THE ORG:CNS:MODEL #: NISERIAL #: NIDEVICE MANUFACTURER DATA: NIUNIQUE IDENTIFIER (UDI) #: NIRETURNED TO NIHON KOHDEN: NATRANSMITTER (TELE)MODEL #: NISERIAL #: NIDEVICE MANUFACTURER DATA: NIUNIQUE IDENTIFIER (UDI) #: NIRETURNED TO NIHON KOHDEN: NA