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 04/19/2024

Event Type  malfunction  

Event Description

The biomedical engineer (bme) reported that the central nurses station (cns) had spontaneously stopped monitoring a bedside monitor (bsm-6000).No patient harm was reported.

Manufacturer Narrative

Details of complaint: the biomedical engineer (bme) reported that the central nurses station (cns) had spontaneously stopped monitoring a bedside monitor (bsm-6000/vmc-cv428).This may have occurred during a wlan transport, but they would like nk to review the logs.They were able to add the bsm-6000 back to the cns to continue monitoring the patient.There were no reports of patient harm or injury.On (b)(60 2024, logs were collected for the cns, sn:(b)(6), and bsm-6000 for nkc to review.The bsm-1700 logs were unable to be collected since they were unsure which one was inside that room at the time.Investigation summary: a definitive root cause could not be determined since we did not receive the bsm-1700 input unit logs, however, from the cns and bsm-6000 logs nkc confirmed that the wlan transport function was used.Based on similar events from this facility, possible cause may include software deficiency for the cns and an unstable network connection during the wlan transport process.Nk service team and nk cits are currently working with the customer to assess their local network environment.Nk also plans to improve the cns software to retain bsm information in case network connection for the bsm is lost during the wlan transport process.The next cns software upgrade version 02-24 is estimated to be released in june 2024.Additional device information: d10 concomitant medical device: the following devices were used in conjunction with the cns: bedside monitors (bsm-6000): model #: ni serial (b)(6) device manufacturer data: ni unique identifier (udi) #: ni returned to nihon kohden: na.

• 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; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 19191079
• MDR Text Key: 341488441
• Report Number: 8030229-2024-04265
• 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: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 04/26/2024

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: 04/19/2024
• Initial Date FDA Received: 04/26/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/03/2017
• 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: BSM-1700; BSM-6000