MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION MU-971RA; CENTRAL MONITOR SYSTEM (CNS-9700A)

Model Number	MU-971RA
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/11/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint report: the biomedical engineer (bme) reported that the telemetry 5 group is not showing up at the central nurse's station (cns).No patient harm was reported.Technicial support suggested for the bme to reboot the cns or org box associated to tele 5 goup.Technical support informed the bme that the model mu-971 has been sunsetted in 2011 and are no longer able to be serviced by nihon kohden and recommeded that they purchase a newer version of cns.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.
Event or Problem Description
The biomedical engineer (bme) reported that the telemetry 5 group is not showing up at the central nurse's station (cns).No patient harm was reported.Technicial support suggested for the bme to reboot the cns or org box associated to tele 5 goup.Technical support informed the bme that the model mu-971 has been sunsetted in 2011 and are no longer able to be serviced by nihon kohden and recommeded that they purchase a newer version of cns.
Event or Problem Description
The biomedical engineer (bme) reported that the telemetry 5 group is not showing up at the central nurse's station (cns).No patient harm was reported.Technical support suggested for the bme to reboot the cns or org box associated to tele 5 goup.Technical support informed the bme that the model mu-971 has been sunsetted in 2011 and are no longer able to be serviced by nihon kohden and recommended that they purchase a newer version of cns.
Additional Manufacturer Narrative
Complaint report: the biomedical engineer (bme) reported that the telemetry 5 group is not showing up at the central nurse's station (cns).No patient harm was reported.Technical support suggested for the bme to reboot the cns or org box associated to tele 5 goup.Technical support informed the bme that the model mu-971 has been sunsetted in 2011 and are no longer able to be serviced by nihon kohden and recommeded that they purchase a newer version of cns.Investigation summary: incident summary/troubleshooting/results: on (b)(6) 2023, the customer reported telemetry group 5 gz was not showing at the central nurse's station (cns), (mu-971ra, serial number (b)(6)).Nk technical recommended that the customer reboot the cns or org associated with the telemetry 5 group.The quality team followed up with the customer on 3 different occasions (3 gfes), but the customer was unresponsive.There was patient involvement when the issue occurred, but no report of patient harm, no injury, nor any adverse event, due to the reported issue.Note: this unit has reached the end of its service life.Root cause analysis: we were unable to confirm the reported issue.A definitive root cause cannot be determined, however, in this case, it is likely the telemetry unit group 5 was not showing up could have been caused by the units having the incorrect settings, the device not being powered on, or duplicate ips.As the customer did not respond to any attempts from the quality team, it is possible the customer was able to resolve the issue on their own.We have also identified several potential causes of bed not showing up issues, which are not limited to, and explained in further detail below: unable to locate bed issues or "registered bed error" issues may arise when a bedside monitor cannot be viewed on the local cns.This issue may arise due to network port issues, improper settings on the device monitor > monitor bed settings screen, the bsm not being powered on, or the cns not being powered on when connecting the bed.Other possibilities could be the ip address is duplicated, the channel is incorrect, the bsm may be damaged, or there may be applicable issues arising from normal wear and tear.Users should ensure that both the bsm and cns are powered on, the ethernet cord is in good working condition, and the connection with the port and bsm is snug.Other resolutions to these errors are powering down the bsm and restarting, powering down the cns and restarting, checking switches to ensure good working order, and looking for damaged components from use that indicate the need for repair.Beds without the correct "monitor beds" settings may fail to show up on the cns.The causes for a bed to fail to appear include user settings, user education, or passwords and user credentials which may prevent users from accessing the monitor beds settings.Time synching may contribute to issues pertaining to adt situations.Resolutions may include adjusting time settings manually or rebooting system to sync with current network settings.Device history: a serial number review of the reported device (pu-681ra, serial number (b)(6)) does not reveal additional related complaints.Complaint history review of the customer's account does not reveal trends for similar complaints.
Additional Manufacturer Narrative
Udi related data quality updates.Corrected information: d1 brand name: corrected the brand name from cns-9700a to mu-971ra.D4 additional device information / model #: corrected the model # from cns-9700a to mu-971ra.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.
Event or Problem Description
The biomedical engineer (bme) reported that the telemetry 5 group is not showing up at the central nurse's station (cns).No patient harm was reported.Technicial support suggested for the bme to reboot the cns or org box associated to tele 5 goup.Technical support informed the bme that the model mu-971 has been sunsetted in 2011 and are no longer able to be serviced by nihon kohden and recommended that they purchase a newer version of cns.

• Brand Name: MU-971RA
• Common Device Name: CENTRAL MONITOR SYSTEM (CNS-9700A)
• Manufacturer (Section D): NIHON KOHDEN CORPORATION; attn: shama mooman; 1-31-4 nishiochia; shinjuku-ku, tokyo 161-8 560; JA 161-8560
• Manufacturer (Section G): NIHON KOHDEN TOMIOKA CORPORATION; attn: shama mooman; 1-1 tajino; tomioka city, gunma 370-2 314; JA 370-2314
• Manufacturer Contact: shama mooman ; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 18066719
• Report Number: 8030229-2023-03848
• Device Sequence Number: 15357471
• Product Code: MHX
• UDI-Device Identifier: 04931921000663
• UDI-Public: (01)04931921000663(21)1235
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K023475
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: MU-971RA
• Device Catalogue Number: MU-971RA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2023
• Supplement Date Received by Manufacturer: 01/15/2024; 01/15/2024
• Initial Report FDA Received Date: 11/03/2023
• Supplement Report FDA Received Date: 01/16/2024; 08/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/19/2008
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown