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

Model Number CNS-6201A

Device Problems Fire (1245); Communication or Transmission Problem (2896); Temperature Problem (3022)

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

Event Date 02/20/2023

Event Type  malfunction  

Manufacturer Narrative

The customer reported that this central nurse's station (cns) displayed communication loss (comm loss).According to the customer, the cns is monitoring bedside monitors (bsm-3000's).Technical support (ts) troubleshot the issue and had the customer reboot the cisco switch, but after doing that, the switch caught on fire.Due to the fire, they are down and unable to monitor patients.Ts provided the customer with the switches part number (a/cbs250-24p) as due to the age of the switches, the customer will have to replace them with a different model as the ones they had are no longer being manufactured.There was no patient injury 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: attempt # 1: 03/07/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: 03/09/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 3 03/13/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 1: 03/07/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: 03/09/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 3 03/13/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 1: 03/07/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: 03/09/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 3 03/13/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Concomitant medical device: the following device was used in conjunction with the cns: bsms: model #: ni, serial #: ni, device manufacturer data: ni, unique identifier (udi) #: ni, returned to nihon kohden: ni.

Event Description

The customer reported that this central nurse's station (cns) displayed communication loss (comm loss).According to the customer, the cns is monitoring bedside monitors (bsm-3000's).Technical support (ts) troubleshot the issue and had the customer reboot the cisco switch, but after doing that, the switch caught on fire.There was no patient injury reported.

Event Description

The customer reported that this central nurse's station (cns) displayed communication loss (comm loss).According to the customer, the cns is monitoring bedside monitors (bsm-3000's).Technical support (ts) troubleshot the issue and had the customer reboot the cisco switch, but after doing that, the switch caught on fire.There was no patient injury reported.

Manufacturer Narrative

Details of complaint: the customer reported that this central nurse's station (cns) displayed communication loss (comm loss).According to the customer, the cns is monitoring bedside monitors (bsm-3000's).Technical support (ts) troubleshot the issue and had the customer reboot the cisco switch, but after doing that, the switch caught on fire.Due to the fire, they are down and unable to monitor patients.Ts provided the customer with the switches part number (a/cbs250-24p) as due to the age of the switches, the customer will have to replace them with a different model as the ones they had are no longer being manufactured.There was no patient injury reported.Investigation summary: the switch is not an nk device.The root cause of the switch failing / "on fire" could not be identified.Manufacturer references # (b)(4) follow up 001.

• 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 ; seibu bldg 2, 4th floor 1-11-2; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 16560611
• MDR Text Key: 311469619
• Report Number: 8030229-2023-03430
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/14/2023

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-6201A
• Device Catalogue Number: PU-621RA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/20/2023
• Initial Date FDA Received: 03/16/2023
• Supplement Dates Manufacturer Received: 06/13/2023
• Supplement Dates FDA Received: 06/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/30/2012
• 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: BEDSIDE MONITORS (BSMS); BEDSIDE MONITORS (BSMS)