MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION CNS-9700A; CENTRAL MONITOR SYSTEM

Model Number	CNS-9700A
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported communication loss (comm loss) on the central nurse's station (cns).There was no patient injury reported.
Additional Manufacturer Narrative
Technical support (ts) troubleshot the issue with no change.Ts informed the customer that it might be an issue with the wall jack in the room.The customer will try to replace the cabling, check the wall jack and will reach out if needed.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.Concomitant medical device: the following device was used in conjunction with the cns: bsm: model #: ni, serial #: ni, device manufacturer data: ni, unique identifier (udi) #: ni, returned to nihon kohden: ni.
Event or Problem Description
The customer reported that the central nurse's station (cns) was in comm loss with the bedside monitors (bsms).There was no patient injury reported.
Additional Manufacturer Narrative
Details of complaint: the customer reported that the central nurse's station (cns) was in comm loss with the bedside monitors (bsms).Technical support (ts) attempted to troubleshoot the issue with no change.Ts informed the customer that it might be an issue with the wall jack in the room.No patient harm was reported.Investigation summary: nihon kohden technical support (nk ts) performed troubleshooting steps identifying the bsms as end of life/ end of service.Nk ts had the customer check the group settings for the bsms, which were set to auto ip.Nk ts had the customer switch out the bsm for a known working device.The device would not show up on the cns.Nk ts advised the customer to replace the cable and check the port in the room being monitored.The customer to call back after a cable replacement and port check.Nk ts followed up with customer with no response to correspondence.With the available information it is reasonable to determine the root cause is the facility's network environment.It was most likely the port in the room or a network switch that needed to be replaced.A review of the serial number history shows no recurrence of the reported issue.Comm loss/signal loss is an error message notifying the user of loss of network communication between the monitoring cns or rns and that of the monitored devices.The message appears on an individual "tile" on the cns, corresponding to the communication loss of the monitored device.Other related events that may cause the issue are accidentally turning off the device, or accidentally unplugging the network cable of the monitored device, or user error.

• Brand Name: CNS-9700A
• Common Device Name: 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: 13253363
• Report Number: 8030229-2022-02332
• Device Sequence Number: 19940555
• Product Code: MHX
• UDI-Device Identifier: 04931921000663
• UDI-Public: 04931921000663
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 04/07/2023

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
• Operator of Device: Health Professional
• Device Model Number: CNS-9700A
• 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: 12/17/2021
• Supplement Date Received by Manufacturer: 03/28/2023
• Initial Report FDA Received Date: 01/13/2022
• Supplement Report FDA Received Date: 04/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/08/2006
• 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
• Concomitant Medical Products and Therapy/Usage Dates: BSM; BSMS
• Patient Sex: Unknown