ORG-9110A

Additional Manufacturer Narrative

THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE MULTIPLE PATIENT RECEIVER (ORG) WAS GETTING INTERMITTENT COMM LOSS THAT WAS ONGOING. THEY HAVE CONFIRMED THE ISSUE IS RELATED TO THIS ORG SPECIFICALLY AND NOT A SWITCH OR NETWORK ISSUE. WHEN SWAPPING THE ORG OUT WITH A SPARE UNIT USING THE SAME CONNECTIONS, THERE ARE NO ISSUES. WHEN THE COMM-LOSS OCCURS, IT HAPPENS ON ALL TELEMETRY TRANSMITTER (TELE) ON THAT UNIT (4 RECEIVER CARDS IN TOTAL). THE COMM-LOSS WILL APPROXIMATELY LAST ANYWHERE FROM 30 SECONDS TO 3 MINUTES. 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. CENTRAL NURSE'S STATION MODEL: PU-681RA SN: (B)(6). TELEMETRY TRANSMITTER MODEL: ZM-531PA SN: (B)(6). TELEMETRY TRANSMITTER MODEL: ZM-541PA SN: (B)(6).

Description of Event or Problem

THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE MULTIPLE PATIENT RECEIVER (ORG) WAS GETTING INTERMITTENT COMM LOSS THAT WAS ONGOING. THEY HAVE CONFIRMED THE ISSUE IS RELATED TO THIS ORG SPECIFICALLY AND NOT A SWITCH OR NETWORK ISSUE. WHEN SWAPPING THE ORG OUT WITH A SPARE UNIT USING THE SAME CONNECTIONS, THERE ARE NO ISSUES. WHEN THE COMM-LOSS OCCURS, IT HAPPENS ON ALL TELEMETRY TRANSMITTER (TELE) ON THAT UNIT (4 RECEIVER CARDS IN TOTAL). THE COMM-LOSS WILL APPROXIMATELY LAST ANYWHERE FROM 30 SECONDS TO 3 MINUTES. NO PATIENT HARM WAS REPORTED.

Description of Event or Problem

THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE MULTIPLE PATIENT RECEIVER (ORG) WAS GETTING INTERMITTENT COMM LOSS THAT WAS ONGOING. THEY HAVE CONFIRMED THE ISSUE IS RELATED TO THIS ORG SPECIFICALLY AND NOT A SWITCH OR NETWORK ISSUE. WHEN SWAPPING THE ORG OUT WITH A SPARE UNIT USING THE SAME CONNECTIONS, THERE ARE NO ISSUES. WHEN THE COMM-LOSS OCCURS, IT HAPPENS ON ALL TELEMETRY TRANSMITTER (TELE) ON THAT UNIT (4 RECEIVER CARDS IN TOTAL). THE COMM-LOSS WILL APPROXIMATELY LAST ANYWHERE FROM 30 SECONDS TO 3 MINUTES. NO PATIENT HARM WAS REPORTED.

Additional Manufacturer Narrative

THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE MULTIPLE PATIENT RECEIVER (ORG) WAS GETTING INTERMITTENT COMM LOSS THAT WAS ONGOING. THEY HAVE CONFIRMED THE ISSUE IS RELATED TO THIS ORG SPECIFICALLY AND NOT A SWITCH OR NETWORK ISSUE. WHEN SWAPPING THE ORG OUT WITH A SPARE UNIT USING THE SAME CONNECTIONS, THERE ARE NO ISSUES. WHEN THE COMM-LOSS OCCURS, IT HAPPENS ON ALL TELEMETRY TRANSMITTER (TELE) ON THAT UNIT (4 RECEIVER CARDS IN TOTAL). THE COMM-LOSS WILL APPROXIMATELY LAST ANYWHERE FROM 30 SECONDS TO 3 MINUTES. NO PATIENT HARM WAS REPORTED. INVESTIGATION CONCLUSION: THE CUSTOMER REPORTED THAT THE MULTIPLE PATIENT RECEIVER (ORG-9110A, SN: (B)(6)) WAS GETTING INTERMITTENT COMMUNICATION LOSS. AN EXCHANGE UNIT WAS SENT TO THE CUSTOMER, AND THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION. DURING EVALUATION, THE CUSTOMER'S REPORTED ISSUE COULD NOT BE DUPLICATED, AND NO ISSUES WERE OBSERVED. AS SUCH, THE ROOT CAUSE OF THE CUSTOMER'S COMPLAINT CANNOT BE DEFINITIVELY ESTABLISHED. A REVIEW OF THE CUSTOMER'S COMPLAINT HISTORY BY SERIAL NUMBER REVEALS NO PREVIOUS REPORTED ISSUES. 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 08/06/2025 EMAILED CUSTOMER VIA MICROSOFT OUTLOOK FOR ALL ITEMS UNDER THE NO INFORMATION SECTION. NO REPLY WAS RECEIVED. ATTEMPT #2 08/12/2025 EMAILED CUSTOMER VIA MICROSOFT OUTLOOK FOR ALL ITEMS UNDER THE NO INFORMATION SECTION. THE CUSTOMER RESPONDED BACK, BUT THEY DID NOT PROVIDE THE ADDITIONAL DEVICE INFORMATION AS REQUESTED. CENTRAL NURSE'S STATION. MODEL: PU-681RA. SN: NI. TELEMETRY TRANSMITTER . MODEL: ZM-531PA. SN: NI. TELEMETRY TRANSMITTER . MODEL: ZM-541PA. 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.