ORG-9110A

Additional Manufacturer Narrative

THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE MULTIPLE PATIENT RECEIVER (ORG) POWER CYCLED TWICE AND GOES BLANK. THEY STATED THAT IT TURNS OFF FOR 30 SECONDS THEN TURNS BACK ON. "COMM-LOSS" IS DISPLAYED ON THE CENTRAL NURSE'S STATION (CNS) IN ALL TELEMETRY TRANSMITTERS ASSIGNED 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. ADDITIONAL DEVICE INFORMATION: THE FOLLOWING FIELD(S) CONTAINS NO INFORMATION (NI), AS ATTEMPTS TO OBTAIN INFORMATION WERE MADE, BUT NOT PROVIDED. D10 CONCOMITANT MEDICAL DEVICE. ATTEMPT #1 09/11/2025 EMAILED CUSTOMER VIA MICROSOFT OUTLOOK FOR ALL ITEMS UNDER THE NO INFORMATION SECTION. NO REPLY WAS RECEIVED. ATTEMPT #2 09/15/2025 EMAILED CUSTOMER VIA MICROSOFT OUTLOOK FOR ALL ITEMS UNDER THE NO INFORMATION SECTION. NO REPLY WAS RECEIVED. ATTEMPT #3 09/17/2025 EMAILED CUSTOMER VIA MICROSOFT OUTLOOK FOR ALL ITEMS UNDER THE NO INFORMATION SECTION. NO REPLY WAS RECEIVED. CENTRAL NURSE'S STATION MODEL: NI. SN: NI. ZM TELEMETRY TRANSMITTERS MODEL: NI. SN: NI.

Description of Event or Problem

THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE MULTIPLE PATIENT RECEIVER (ORG) POWER CYCLED TWICE AND GOES BLANK. THEY STATED THAT IT TURNS OFF FOR 30 SECONDS THEN TURNS BACK ON. "COMM-LOSS" IS DISPLAYED ON THE CENTRAL NURSE'S STATION (CNS) IN ALL TELEMETRY TRANSMITTERS ASSIGNED TO THIS ORG. NO PATIENT HARM WAS REPORTED.

Additional Manufacturer Narrative

THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE MULTIPLE PATIENT RECEIVER (ORG) POWER CYCLED TWICE AND GOES BLANK. THEY STATED THAT IT TURNS OFF FOR 30 SECONDS THEN TURNS BACK ON. "COMM-LOSS" IS DISPLAYED ON THE CENTRAL NURSE'S STATION (CNS) IN ALL TELEMETRY TRANSMITTERS ASSIGNED TO THIS ORG. NO PATIENT HARM WAS REPORTED. INVESTIGATION CONCLUSION: THE EVALUATION OF THE RETURNED DEVICE SHOWS THAT THIS COMPLAINT IS NOT CONFIRMED. THEREFORE, THE DEFINITIVE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED. ADDITIONAL DEVICE INFORMATION: THE FOLLOWING FIELD(S) CONTAINS NO INFORMATION (NI), AS ATTEMPTS TO OBTAIN INFORMATION WERE MADE, BUT NOT PROVIDED. D10 CONCOMITANT MEDICAL DEVICE. ATTEMPT #1: 09/11/2025 EMAILED CUSTOMER VIA MICROSOFT OUTLOOK FOR ALL ITEMS UNDER THE NO INFORMATION SECTION. NO REPLY WAS RECEIVED. ATTEMPT #2: 09/15/2025 EMAILED CUSTOMER VIA MICROSOFT OUTLOOK FOR ALL ITEMS UNDER THE NO INFORMATION SECTION. NO REPLY WAS RECEIVED. ATTEMPT #3: 09/17/2025 EMAILED CUSTOMER VIA MICROSOFT OUTLOOK FOR ALL ITEMS UNDER THE NO INFORMATION SECTION. NO REPLY WAS RECEIVED. CENTRAL NURSE'S STATION: MODEL: NI. SN: NI. ZM TELEMETRY TRANSMITTERS: MODEL: NI. SN: NI. ADDITIONAL INFORMATION: B4 DATE OF THIS REPORT.. D9 DEVICE AVAILABLE FOR EVALUATION. 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 THE MULTIPLE PATIENT RECEIVER (ORG) POWER CYCLED TWICE AND GOES BLANK. THEY STATED THAT IT TURNS OFF FOR 30 SECONDS THEN TURNS BACK ON. "COMM-LOSS" IS DISPLAYED ON THE CENTRAL NURSE'S STATION (CNS) IN ALL TELEMETRY TRANSMITTERS ASSIGNED TO THIS ORG. NO PATIENT HARM WAS REPORTED.