ORG-9110A

Additional Manufacturer Narrative

DETAILS OF THE COMPLAINT: THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE MULTIPLE PATIENT RECEIVER (ORG) IS SHOWING SIGNAL LOSS. THE ORG WAS REBOOTED BUT NOTHING HAPPENED. THEY REPLACED IT WITH A SPARE ORG ON A NEWLY PROGRAMMED SWITCH PORT, AND IT WORKED RIGHT AWAY. NO PATIENT HARM WAS REPORTED. INVESTIGATION CONCLUSION: ROOT CAUSE ANALYSIS: THE REPORTED ISSUE COULD NOT BE DUPLICATED OR CONFIRMED. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. UPON EVALUATION FROM THE REPAIR CENTER, THE UNIT DID NOT DISPLAY ANY SIGNAL LOSS ERROR MESSAGES. THE UNIT WAS TESTED AND CHECKED RECEPTION WITH CNS ON ALL 8 BEDS WITHOUT ANY SIGNAL LOSS ISSUES. THE ISSUE IS MOST LIKELY ON THE CUSTOMER'S SIDE PERTAINING TO NETWORK, ACCESS POINT OR A PORT. AN OVERVIEW OF SIGNAL LOSS AND ITS POTENTIAL CAUSES IS DETAILED BELOW. POTENTIAL CAUSE(S)/MITIGATION OF ISSUES: SIGNAL LOSS OCCURS WHEN THERE IS LOSS OF COMMUNICATION BETWEEN THE ORG RECEIVER AND ZM TRANSMITTER. THE ORG MULTI-PATIENT RECEIVER COLLECTS AND PROCESSES INFORMATION FROM THE ZM TRANSMITTERS AND RELAYS THIS TO THE CNS. POSSIBLE CAUSES OF A COMMUNICATION ERROR MESSAGE COULD BE WHEN THE NETWORK CABLE OR CONNECTOR ON THE CNS OR ORG IS DISCONNECTED OR FAULTY, IF THE SETTINGS OF THE MONITOR ARE NOT THE SAME AS THE ORG/ZM OR IF THERE ARE DUPLICATE IP ADDRESSES BEING USED BY MORE THAN ONE BED. COMMUNICATION LOSS/SIGNAL LOSS MAY ALSO OCCUR DUE TO ISSUES WITH THE CUSTOMER'S NETWORK ENVIRONMENT. NETWORK ACCESS POINT OVERLOAD MAY CAUSE UNSTABLE NETWORK CONNECTION AND MAY CAUSE DEVICES TO RANDOMLY DROP CONNECTION OR CAUSE THE HOST TABLE TO BECOME UNBALANCED. OTHER DEVICES IN THE HOSPITAL FACILITY MAY ALSO CAUSE INTERFERENCE WHICH COULD CAUSE SIGNAL LOSS. COMMUNICATION LOSS/SIGNAL LOSS MAY ALSO OCCUR AFTER A POWER LOSS, AS THE NETWORK SERVER MAY NOT PROPERLY BOOT UP AFTER AN UNEXPECTED SHUTDOWN. DEVICE HISTORY: A SERIAL NUMBER REVIEW OF THE REPORTED DEVICE (MODEL: ORG-9110A, ZM TELEMETRY TRANSMITTERS MODEL NI, SERIAL NUMBER: (B)(6), NI) DOES NOT REVEAL ADDITIONAL RELATED COMPLAINTS. COMPLAINT HISTORY REVIEW OF THE CUSTOMER'S ACCOUNT DOES NOT REVEAL TRENDS FOR SIMILAR COMPLAINTS. ADDITIONAL DEVICE INFORMATION: THE FOLLOWING FIELDS CONTAINS NO INFORMATION (NI), AS ATTEMPTS TO OBTAIN INFORMATION WERE MADE, BUT THE INFORMATION WAS NOT PROVIDED. D10: CONCOMITANT MEDICAL DEVICE. ATTEMPT #1: 01/20/2025 EMAILED CUSTOMER VIA MICROSOFT OUTLOOK FOR ALL ITEMS UNDER THE NO INFORMATION SECTION. THE CUSTOMER RESPONDED BACK WITH COMPLAINT DETAILS, BUT THEY DID NOT PROVIDE THE ADDITIONAL DEVICE INFORMATION AS REQUESTED. CENTRAL NURSE'S STATION. MODEL: NI. SN: NI. DEVICE MANUFACTURER DATE: NI. UNIQUE IDENTIFIER (UDI) #: NI. RETURNED TO NIHON KOHDEN: NOT RETURNED. ZM TELEMETRY TRANSMITTER(S) MODEL: NI. SN: NI. DEVICE MANUFACTURER DATE: NI. UNIQUE IDENTIFIER (UDI) #: NI. RETURNED TO NIHON KOHDEN: NOT RETURNED. 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 THE MULTIPLE PATIENT RECEIVER (ORG) IS SHOWING SIGNAL LOSS. THE ORG WAS REBOOTED BUT NOTHING HAPPENED. THEY REPLACED IT WITH A SPARE ORG ON A NEWLY PROGRAMMED SWITCH PORT, AND IT WORKED RIGHT AWAY. NO PATIENT HARM WAS REPORTED.

Description of Event or Problem

THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE MULTIPLE PATIENT RECEIVER (ORG) IS SHOWING SIGNAL LOSS. THE ORG WAS REBOOTED BUT NOTHING HAPPENED. THEY REPLACED IT WITH A SPARE ORG ON A NEWLY PROGRAMMED SWITCH PORT, AND IT WORKED RIGHT AWAY. NO PATIENT HARM WAS REPORTED.

Additional Manufacturer Narrative

THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE MULTIPLE PATIENT RECEIVER (ORG) IS SHOWING SIGNAL LOSS. THE ORG WAS REBOOTED BUT NOTHING HAPPENED. THEY REPLACED IT WITH A SPARE ORG ON A NEWLY PROGRAMMED SWITCH PORT, AND IT WORKED RIGHT AWAY. 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 FIELDS CONTAINS NO INFORMATION (NI), AS ATTEMPTS TO OBTAIN INFORMATION WERE MADE, BUT THE INFORMATION WAS NOT PROVIDED. D10: CONCOMITANT MEDICAL DEVICE. CENTRAL NURSE'S STATION MODEL: NI SN: (B)(6) DEVICE MANUFACTURER DATE: NI UNIQUE IDENTIFIER (UDI) #: (B)(4) RETURNED TO NIHON KOHDEN: NOT RETURNED. ZM TELEMETRY TRANSMITTER(S) MODEL: NI SN: (B)(6) DEVICE MANUFACTURER DATE: NI UNIQUE IDENTIFIER (UDI) #: (B)(4) RETURNED TO NIHON KOHDEN: NOT RETURNED.