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

Model Number CNS-6801A

Device Problem Communication or Transmission Problem (2896)

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

Event Date 12/01/2021

Event Type  malfunction  

Event Description

The customer reported that their central nurse's station (cns) is displaying communication loss for 2 monitored bedside monitors (bsm's).This occurred after these bsm's were moved to another unit.No harm or injury was reported.

Manufacturer Narrative

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.

Manufacturer Narrative

Details of complaint: the customer reported that the central nurse's station (cns) was displaying comm loss for 2 bedside monitors (bsms) after moving the bsms to another cns.No patient harm or injury was reported.Investigation summary: troubleshooting indicated configuration or physical issues with the network path.Further troubleshooting was requested, but the customer hurried off the phone before additional details were gathered.The troubleshooting notes suggested network configuration and/or physical network equipment should be verified to ensure there was no issue.The service history for this facility was reviewed for the period between 11/2021 and 1/2022 for issues related to networking and/or communication loss.The following events were found: ticket (b)(4) - communication loss attributable to network issues.Ticket (b)(4) - a bedside monitor had a duplicate ip address.Ticket - the customer reported communication loss on gz telemetry devices and needed to restart the gateway service.The tickets above indicate network issues.Information in the current ticket shows no indication of a device malfunction.Based on this information, it is concluded that the probable cause for the reported communication loss event was related to networking, not device failure.

Event Description

The customer reported that the central nurse's station (cns) was displaying comm loss for 2 bedside monitors (bsms) after moving the bsms to another cns.No harm or injury was reported.

• 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 ; 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: 13122542
• MDR Text Key: 285044180
• Report Number: 8030229-2021-02266
• 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: K102376
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/04/2023

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
• Device Catalogue Number: PU-681RA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/01/2021
• Initial Date FDA Received: 12/30/2021
• Supplement Dates Manufacturer Received: 03/29/2023
• Supplement Dates FDA Received: 04/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/18/2017
• 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 (BSM'S); BEDSIDE MONITORS (BSMS)