ORG-9110A

Description of Event or Problem

THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE CENTRAL NURSES STATION (CNS) DISPLAYED AN ERROR MESSAGE "COMMUNICATION LOSS" EVERY FEW MINUTES. TECHNICAL SUPPORT (TS) HAD BIOMED REBOOT THE MULTIPLE PATIENT RECEIVER (ORG) AND SWITCH THE ETHERNET CABLE. THEY SWAPPED THE ETHERNET CABLE FROM A KNOWN WORKING UNIT ON THE SAME CNS, BUT THE ISSUE PERSISTED. NO REPORTS OF PATIENT HARM.

Additional Manufacturer Narrative

THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE CENTRAL NURSES STATION (CNS) DISPLAYED AN ERROR MESSAGE "COMMUNICATION LOSS" EVERY FEW MINUTES. TECHNICAL SUPPORT (TS) HAD BIOMED REBOOT THE MULTIPLE PATIENT RECEIVER (ORG) AND SWITCH THE ETHERNET CABLE. THEY SWAPPED THE ETHERNET CABLE FROM A KNOWN WORKING UNIT ON THE SAME CNS, BUT THE ISSUE PERSISTED. NO REPORTS OF PATIENT HARM. 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: D10 CONCOMITANT MEDICAL DEVICE: THE FOLLOWING DEVICE(S) WERE USED IN CONJUNCTION WITH THE ORG: CNS: MODEL #: NI SERIAL #: NI DEVICE MANUFACTURER DATA: NI UNIQUE IDENTIFIER (UDI) #: NI RETURNED TO NIHON KOHDEN: NA. ZM TRANSMITTERS: MODEL #: NI SERIAL #: NI DEVICE MANUFACTURER DATA: NI UNIQUE IDENTIFIER (UDI) #: NI RETURNED TO NIHON KOHDEN: NA.

Description of Event or Problem

THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE CENTRAL NURSES STATION (CNS) DISPLAYED AN ERROR MESSAGE "COMMUNICATION LOSS" EVERY FEW MINUTES. TECHNICAL SUPPORT (TS) HAD BIOMED REBOOT THE MULTIPLE PATIENT RECEIVER (ORG) AND SWITCH THE ETHERNET CABLE. THEY SWAPPED THE ETHERNET CABLE FROM A KNOWN WORKING UNIT ON THE SAME CNS, BUT THE ISSUE PERSISTED. NO REPORTS OF PATIENT HARM.

Additional Manufacturer Narrative

THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE CENTRAL NURSES STATION (CNS) DISPLAYED AN ERROR MESSAGE "COMMUNICATION LOSS" EVERY FEW MINUTES. TECHNICAL SUPPORT (TS) HAD BIOMED REBOOT THE MULTIPLE PATIENT RECEIVER (ORG) AND SWITCH THE ETHERNET CABLE. THEY SWAPPED THE ETHERNET CABLE FROM A KNOWN WORKING UNIT ON THE SAME CNS, BUT THE ISSUE PERSISTED. NO REPORTS OF PATIENT HARM. INVESTIGATION SUMMARY: TESTING AT THE REPAIR CENTER COULD NOT DUPLICATE THE COMMUNICATION LOSS, EVEN AFTER EXTENDED BURN-IN. THE UNIT WAS RETURNED AS CONDITION-NO-DEFECT (CND), WITH THE LIKELY CAUSE ATTRIBUTED TO A NETWORK CONFIGURATION OR DUPLICATE IP CONFLICT AT THE CUSTOMER SITE. THE ROOT CAUSE COULD NOT BE DETERMINED. ADDITIONAL DEVICE INFORMATION: D10 CONCOMITANT MEDICAL DEVICE: THE FOLLOWING DEVICE(S) WERE USED IN CONJUNCTION WITH THE ORG: CNS: MODEL #: NI SERIAL #: NI DEVICE MANUFACTURER DATA: NI UNIQUE IDENTIFIER (UDI) #: NI RETURNED TO NIHON KOHDEN: NA. ZM TRANSMITTERS: MODEL #: NI SERIAL #: NI DEVICE MANUFACTURER DATA: NI UNIQUE IDENTIFIER (UDI) #: NI RETURNED TO NIHON KOHDEN: NA. 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.