MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION CNS-6801A; CENTRAL MONITOR SYSTEM

Model Number CNS-6801A

Device Problems Communication or Transmission Problem (2896); Wireless Communication Problem (3283)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/07/2020

Event Type  malfunction  

Manufacturer Narrative

The customer reported that they were having site-wide communication loss.Nk is continuing to work with the customer to resolve the issue.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 contain no information (ni), as attempts to obtain information were made, but not provided: brand name.Model number.Catalog number.Serial number.Udi number.Approximate age of device.No serial number was provided, so the age of the device is unknown.Pma/510(k) number.Device manufacturer date.Concomitant medical device: the following devices were being used in conjunction with the cns: bsms: no model or serial numbers were provided.

Event Description

The customer reported that they were having site-wide communication loss.No patient harm was reported.

Event Description

The customer reported that they were having site-wide communication loss.No patient harm was reported.

Manufacturer Narrative

Details of complaint: the customer reported they were having site-wide comm loss with all the monitored bedside monitors (bsms).No patient harm or injury was reported.Service requested / performed: troubleshooting.Investigation summary: nihon kohden technical support (nk ts) performed troubleshooting steps with the customer and discovered the network was operating on one switch.Nk ts requested assistance from clinical information technology support (cits) to further troubleshoot the issue.Cits verified ip and host table addresses but found the only working bed to have the same ip as the server.Two of the beds had the same address.And the bsm's were all changed to auto ip with different settings.Cits discovered the disconnect was the firewall between the hospital network and the enterprise gateway.The wlan bridge needed the ip and mac addresses of the bsm's.Cits advised the facility to troubleshoot the issue on their end as we do not have access to the facility's network.The root cause is determined to be environment (facility network).Permissions for ip and mac address are being prevented due to the network settings.Additional information: b4 date of this report d8 was this device serviced by a third party? g3 date received by manufacturer g6 type of report h2 if follow-up, what type? h6 event problem and evaluation codes h10 additional manufacturer narrative.

• Brand Name: CNS-6801A
• 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: 10371007
• MDR Text Key: 204203092
• Report Number: 8030229-2020-00428
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 04931921131640
• UDI-Public: 04931921131640
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 08/05/2020,01/23/2023

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-6801A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/05/2020
• Distributor Facility Aware Date: 07/07/2020
• Event Location: Hospital
• Date Report to Manufacturer: 08/05/2020
• Initial Date Manufacturer Received: 07/07/2020
• Initial Date FDA Received: 08/05/2020
• Supplement Dates Manufacturer Received: 01/20/2023
• Supplement Dates FDA Received: 01/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: BSMS; BSMS