MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION CNS-6201A; CENTRAL MONITOR SYSTEM

Model Number CNS-6201A

Device Problems Use of Incorrect Control/Treatment Settings (1126); Use of Device Problem (1670); Application Program Problem (2880); Communication or Transmission Problem (2896)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/09/2020

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer (bme) reported that they received a network disconnect error on the central nurse's station (cns) and stated that the error pops up when trying to load the cns application.They confirmed that the ethernet cable is plugged into the correct port and checked the wall port to make sure that the port on the wall was fully connected as well.Nihon kohden technical support (tech support) had them go to windows and change the ip address from manual to auto.Then the biomed rebooted the cns and the application came back up as normal.Issue resolved.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.The following fields contains no information (ni), as attempts to obtain information were made, but not provided.Additional model information: concomitant medical device: the following device(s) bedside monitors were being used in conjunction with the cns, but the serial number information was noted as no information (ni), as attempts to obtain information were made but information was not provided.Bedside monitors model: bsm-6301a sn: ni.

Event Description

The biomedical engineer (bme) reported that they received a network disconnect error on the central nurse's station (cns) and stated that the error pops up when trying to load the cns application.They confirmed that the ethernet cable is plugged into the correct port and checked the wall port to make sure that the port on the wall was fully connected as well.Nihon kohden technical support (tech support) had them go to windows and change the ip address from manual to auto.Then the biomed rebooted the cns and the application came back up as normal.Issue resolved.No patient harm was reported.

Manufacturer Narrative

Details of complaint: the biomedical engineer (bme) reported they received a "network disconnect" error on the central nurse's station (cns) and stated that the error would pop up when trying to load the cns application.They confirmed the ethernet cable was plugged into the correct cns and wall ports.Nihon kohden technical support (nk ts) advised that they change the ip address from manual to auto in windows.When rebooted the cns the application came back up normally.No patient harm was reported.Service requested / performed: troubleshooting.Investigation summary: during troubleshooting, it was identified that the ip address for the cns was set to a manual ip.The customer indicated that the ip scheme for their facility is auto ip.Nk ts assisted the customer in changing the ip address setting of the cns from manual to auto.After the cns was set to auto ip, the issue was resolved.Based on the available information, the most probable cause of the issue is incorrect setup of the device.Since the cns was in a different ip setting than the other devices on the network, it was unable to communicate with the other devices, resulting in the error.The issue was caused by incorrect settings.If the correct setting was used, the issue would have not occurred.

Event Description

The biomedical engineer (bme) reported that they received a network disconnect error on the central nurse's station (cns) and stated that the error pops up when trying to load the cns application.They confirmed that the ethernet cable is plugged into the correct port and checked the wall port to make sure that the port on the wall was fully connected as well.Nihon kohden technical support (tech support) had them go to windows and change the ip address from manual to auto.Then the biomed rebooted the cns and the application came back up as normal.Issue resolved.No patient harm was reported.

• Brand Name: CNS-6201A
• Type of Device: CENTRAL MONITOR SYSTEM
• 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 ; safety mgmt dept, quality mgmt; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 10806865
• MDR Text Key: 235023153
• Report Number: 8030229-2020-00661
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 04931921114131
• UDI-Public: 04931921114131
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102376
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 10/27/2022

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
• Device Operator: Health Professional
• Device Model Number: CNS-6201A
• Device Catalogue Number: PU-621RA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/09/2020
• Initial Date FDA Received: 11/08/2020
• Supplement Dates Manufacturer Received: 06/15/2022
• Supplement Dates FDA Received: 10/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/22/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: BSM-6301A; BSM-6301A