ORG-9100A

Description of Event or Problem

THE BIOMEDICAL ENGINEER (BSM) REPORTED THAT THE MULTIPLE PATIENT RECEIVER (ORG) IS HAVING INTERMITTENT SIGNAL LOSS WITH CONNECTED DEVICES WHICH HAS BEEN HAPPENING THROUGH THE ENTIRE FACILITY EVER SINCE THE INSTALL HAD BEEN CONCLUDED. NO PATIENT HARM WAS REPORTED. THE BME REQUESTED AN ON-SITE SERVICE FROM NIHON KOHDEN TO DETERMINE THE CAUSE OF THE REPORTED ISSUES.

Additional Manufacturer Narrative

THE BIOMEDICAL ENGINEER (BSM) REPORTED THAT THE MULTIPLE PATIENT RECEIVER (ORG) IS HAVING INTERMITTENT SIGNAL LOSS WITH CONNECTED DEVICES WHICH HAS BEEN HAPPENING THROUGH THE ENTIRE FACILITY EVER SINCE THE INSTALL HAD BEEN CONCLUDED. NO PATIENT HARM WAS REPORTED. THE BME REQUESTED AN ON-SITE SERVICE FROM NIHON KOHDEN TO DETERMINE THE CAUSE OF THE REPORTED ISSUES. 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(S) WAS USED IN CONJUNCTION WITH THE ORG, HOWEVER, THE MODEL NUMBER AND SERIAL NUMBERS ARE NO INFORMATION (NI) AS ATTEMPTS WERE MADE TO RETRIEVE THE INFORMATION, BUT NONE HAS BEEN RECEIVED. ZM TRANSMITTERS: MODEL #: NI. SERIAL #: NI.

Additional Manufacturer Narrative

DETAILS OF COMPLAINT: THE BIOMEDICAL ENGINEER (BSM) REPORTED THAT THE MULTIPLE PATIENT RECEIVER (ORG) WAS IN INTERMITTENT SIGNAL LOSS WITH THE TELEMETRY TRANSMITTERS. THIS WAS A CONTINUOUS ISSUE THROUGHOUT THE FACILITY SINCE THE CONCLUSION OF THE INSTALL. NO PATIENT HARM WAS REPORTED. INVESTIGATION SUMMARY: FOR WIRELESS ZM TELEMETRY TRANSMITTERS CONNECTED TO THE BEDSIDE MONITOR, A "SIGNAL LOSS" MESSAGE IS DISPLAYED RATHER THAN "COMMUNICATION LOSS," IF THE ISSUE OCCURS BETWEEN THE ORG RECEIVER AND THE ZM TRANSMITTER. HOWEVER, COMMUNICATION LOSS WITH THE ORG RECEIVER DEVICE WOULD TRIGGER A "COMMUNICATION LOSS" MESSAGE FOR UP TO 8 CONNECTED ZM TRANSMITTERS. OTHER RELATED EVENTS THAT MAY CAUSE THE ISSUE ARE ACCIDENTALLY TURNING OFF THE DEVICE, AND ACCIDENTALLY UNPLUGGING THE NETWORK CABLE OF THE MONITORED DEVICE (USER ERROR). SIGNAL LOSS MAY ALSO OCCUR DUE TO ISSUES WITH THE CUSTOMER'S NETWORK ENVIRONMENT. NETWORK ACCESS POINT OVERLOAD MAY CAUSE AN UNSTABLE NETWORK CONNECTION AND MAY CAUSE DEVICES TO RANDOMLY DROP THEIR CONNECTION. FOR TRANSMITTERS, IF THEY ARE ASSIGNED TO ADJACENT CHANNELS OF THE NETWORK, THERE COULD BE RADIO WAVE INTERFERENCE WHICH MAY CAUSE SIGNAL LOSS. OTHER DEVICES IN THE HOSPITAL FACILITY MAY ALSO CAUSE INTERFERENCE WHICH COULD CAUSE SIGNAL LOSS. SIGNAL LOSS MAY ALSO OCCUR AFTER A POWER LOSS, AS THE NETWORK SERVER MAY NOT PROPERLY BOOT UP AFTER AN UNEXPECTED SHUTDOWN. AS THERE WERE NO DEVICES RETURNED ASSOCIATED WITH THIS EVENT, IT IS UNLIKELY THAT THE CAUSE OF THE ISSUE WAS RELATED TO A DEVICE MALFUNCTION. POSSIBLE CAUSES MAY BE RELATED TO ENVIRONMENTAL FACTORS OR THE HOSPITAL'S NETWORK ENVIRONMENT ISSUES. THE FOLLOWING FIELDS CONTAIN NO INFORMATION (NI), AS ATTEMPTS TO THE OBTAIN INFORMATION WERE MADE, BUT NOT PROVIDED: ATTEMPT # 1: 03/07/2022 EMAILED THE CUSTOMER VIA MICROSOFT OUTLOOK FOR ALL INFORMATION IN THE NI LIST ABOVE: NO REPLY WAS RECEIVED. ATTEMPT # 2: 03/18/2022 EMAILED THE CUSTOMER VIA MICROSOFT OUTLOOK FOR ALL INFORMATION IN THE NI LIST ABOVE: NO REPLY WAS RECEIVED. ATTEMPT # 3: 03/22/2022 EMAILED THE CUSTOMER VIA MICROSOFT OUTLOOK FOR ALL INFORMATION IN THE NI LIST ABOVE: NO REPLY WAS RECEIVED. ADDITIONAL DEVICE INFORMATION: D10 CONCOMITANT MEDICAL DEVICE: THE FOLLOWING DEVICES WERE USED IN CONJUNCTION WITH THE ORG. HOWEVER, THE MODEL AND SERIAL NUMBERS ARE LISTED AS NO INFORMATION (NI) AS ATTEMPTS TO OBTAIN THE INFORMATION WERE MADE, BUT NOT PROVIDED. ZM TRANSMITTERS: MODEL #: NI. SERIAL #: NI.

Description of Event or Problem

THE BIOMEDICAL ENGINEER (BSM) REPORTED THAT THE MULTIPLE PATIENT RECEIVER (ORG) WAS IN INTERMITTENT SIGNAL LOSS WITH THE TELEMETRY TRANSMITTERS. THIS WAS A CONTINUOUS ISSUE THROUGHOUT THE FACILITY SINCE THE CONCLUSION OF THE INSTALL. NO PATIENT HARM WAS REPORTED.

Description of Event or Problem

THE BIOMEDICAL ENGINEER (BSM) REPORTED THAT THE MULTIPLE PATIENT RECEIVER (ORG) WAS IN INTERMITTENT SIGNAL LOSS WITH THE TELEMETRY TRANSMITTERS. THIS WAS A CONTINUOUS ISSUE THROUGHOUT THE FACILITY SINCE THE CONCLUSION OF THE INSTALL. NO PATIENT HARM WAS REPORTED.

Additional Manufacturer Narrative

**UDI RELATED DATA QUALITY UPDATES** CORRECTED INFORMATION: D4 ADDITIONAL DEVICE INFORMATION / PRIMARY UNIQUE DEVICE IDENTIFIER (UDI) #: CORRECTED THE UDI # TO INCLUDE THE PI INFORMATION. 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. ADDITIONAL INFORMATION: B4 DATA OF THIS REPORT G6 TYPE OF REPORT H2 IF FOLLOW UP, WHAT TYPE?