ORG-9100A

Additional Manufacturer Narrative

THE CUSTOMER REPORTED THAT THIS MULTIPLE PATIENT RECEIVER (ORG) IS EXPERIENCING INTERMITTENT COMMUNICATION LOSS. THEIR CENTRAL NURSE'S STATION (CNS) DID NOT NOTIFY THEM OF THIS COMMUNICATION LOSS AND THEY ONLY FOUND OUT ABOUT IT BY REVIEWING THE ORG LOGS. THE CUSTOMER CHANGED THEIR PATIENTS FROM TRANSMITTERS TO BEDSIDE MONITORS IN ORDER TO GET THE COMMUNICATION LOSS ISSUE TO GO AWAY. NO HARM OR INJURY 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: CONCOMITANT MEDICAL DEVICE: THE FOLLOWING DEVICE WAS USED IN CONJUNCTION WITH THE ORG: CNS: MODEL #: NI. SERIAL #: NI. DEVICE MANUFACTURER DATA: NI. UNIQUE IDENTIFIER (UDI) #: NI.

Description of Event or Problem

THE CUSTOMER REPORTED THAT THIS MULTIPLE PATIENT RECEIVER (ORG) IS EXPERIENCING INTERMITTENT COMMUNICATION LOSS. THEIR CENTRAL NURSE'S STATION (CNS) DID NOT NOTIFY THEM OF THIS COMMUNICATION LOSS AND THEY ONLY FOUND OUT ABOUT IT BY REVIEWING THE ORG LOGS. THE CUSTOMER CHANGED THEIR PATIENTS FROM TRANSMITTERS TO BEDSIDE MONITORS IN ORDER TO GET THE COMMUNICATION LOSS ISSUE TO GO AWAY. NO HARM OR INJURY WAS REPORTED.

Additional Manufacturer Narrative

DETAILS OF COMPLAINT: THE CUSTOMER REPORTED THAT THE MULTIPLE PATIENT RECEIVER (ORG) WAS EXPERIENCING INTERMITTENT COMMUNICATION LOSS. THE CENTRAL NURSE'S STATION (CNS) DID NOT NOTIFY THEM OF THE COMMUNICATION LOSS, WHICH THEY DISCOVERED WHEN REVIEWING THE ORG LOGS. NO PATIENT HARM WAS REPORTED. INVESTIGATION SUMMARY: AS THE CUSTOMER WAS NOT ABLE TO PROVIDE DEVICE LOGS IN A TIMELY MANNER REQUIRED FOR ANALYSIS, A ROOT CAUSE OF THE COMMUNICATION LOSS COULD NOT BE DETERMINED. THE CAUSE FOR THE INITIAL OCCURRENCE WAS RELATED TO NETWORK CONFIGURATION AS THE CNS'S IP WAS NOT ENTERED INTO THE HOST TABLE. POSSIBLE CAUSES OF COMMUNICATION LOSS FROM THE ORG MAY INCLUDE INCOMPATIBLE SOFTWARE VERSIONS BETWEEN THE ORG AND CNS, OR USER ERROR WITH THE ORG'S NETWORK SETTINGS, SUCH AS INCORRECT NETWORK COMMUNICATION PROTOCOL. THE CUSTOMER SHOULD ENSURE DEVICES WITHIN THE PATIENT MONITORING NETWORK ARE ON COMPATIBLE SOFTWARE VERSIONS AND ON THE SAME NET PROTOCOL SETTING. A REVIEW OF THE DEVICE'S SERIAL NUMBER DOES NOT SHOW ANY OTHER COMPLAINTS. ATTEMPT #1 03/29/2022 EMAILED CUSTOMER VIA MICROSOFT OUTLOOK FOR ALL ITEMS UNDER THE NO INFORMATION SECTION. NO REPLY WAS RECEIVED. ATTEMPT #2 04/05/2022 EMAILED CUSTOMER VIA MICROSOFT OUTLOOK FOR ALL ITEMS UNDER THE NO INFORMATION SECTION. NO REPLY WAS RECEIVED. ATTEMPT #3 04/12/2022 EMAILED CUSTOMER VIA MICROSOFT OUTLOOK FOR ALL ITEMS UNDER THE NO INFORMATION SECTION. NO REPLY WAS RECEIVED. ADDITIONAL DEVICE INFORMATION: D10 CONCOMITANT MEDICAL DEVICE: THE FOLLOWING DEVICE WAS USED IN CONJUNCTION WITH THE MODEL #: NI. SERIAL #: NI. DEVICE MANUFACTURER DATA: NI. UNIQUE IDENTIFIER (UDI) #: NI.

Description of Event or Problem

THE CUSTOMER REPORTED THAT THE MULTIPLE PATIENT RECEIVER (ORG) WAS EXPERIENCING INTERMITTENT COMMUNICATION LOSS. THE CENTRAL NURSE'S STATION (CNS) DID NOT NOTIFY THEM OF THE COMMUNICATION LOSS, WHICH THEY DISCOVERED WHEN REVIEWING THE ORG LOGS. NO HARM OR INJURY WAS REPORTED.

Additional Manufacturer Narrative

THIS IS A CORRECTION TO THE SUSPECT MEDICAL DEVICE INVOLVED IN THE REPORTED EVENT, SPECIFICALLY THE UNIQUE DEVICE IDENTIFIER (UDI) INFORMATION IN SECTION D OF THE FDA FORM 3500A.

Description of Event or Problem

THE CUSTOMER REPORTED THAT THE MULTIPLE PATIENT RECEIVER (ORG) WAS EXPERIENCING INTERMITTENT COMMUNICATION LOSS. THE CENTRAL NURSE'S STATION (CNS) DID NOT NOTIFY THEM OF THE COMMUNICATION LOSS, WHICH THEY DISCOVERED WHEN REVIEWING THE ORG LOGS. NO HARM OR INJURY WAS REPORTED.