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

Model Number CNS-6201A

Device Problems No Display/Image (1183); Connection Problem (2900)

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

Event Date 06/06/2022

Event Type  malfunction  

Event Description

The biomedical engineer (bme) reported that the central nurse's station (cns) had frozen.The bme did a hard reboot, and afterwards, the cns was giving a "network service disconnect" error message.No patient harm was reported.Nihon kohden technician had the bme re-seat the ethernet cable on the cns tower and wall.The bme rebooted the cns again and then the cns came back up and issue is resolved.

Manufacturer Narrative

The biomedical engineer (bme) reported that the central nurse's station (cns) had frozen.The bme did a hard reboot, and afterwards, the cns was giving a "network service disconnect" error message.No patient harm was reported.Nihon kohden technician had the bme re-seat the ethernet cable on the cns tower and wall.The bme rebooted the cns again and then the cns came back up and issue is resolved.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.Attempt #1: 07/01/2022: left voice message for customer for all items under the no information section.No response was received.07/01/2022: emailed the customer via microsoft outlook for all items under the no information section.No reply was received.

Event Description

The biomedical engineer (bme) reported that the software application for the central nurse's station (cns) froze.After a hard reboot, the cns gave a "network service disconnect" error message.No patient harm was reported.

Manufacturer Narrative

Details of complaint: the biomedical engineer (bme) reported that the software application for the central nurse's station (cns) froze.No patient harm was reported.Investigation summary: after a hard reboot, the cns gave a "network service disconnect" error message.Technical support (ts) had the bme reseat the ethernet cable on the cns tower and in the wall outlet, then reboot again, which resolved the issue.Based on the available information, nk was able to confirm the reported issue was possibly due to a network connectivity issue, (due to a user related set up error).A review of historical data indicates the device, (pu-621ra-c, serial number (b)(6), was delivered to the customer on 05/31/2014, and the warranty expired on 05/31/2019.During a serial number review, this was the only complaint at this facility for this device, in the past (3) three years.Based on review, this is an isolated incident.A significant trend that would suggest a design or manufacturing issue or warrant any further corrective action, has not been observed.A review of the customer's account found that this was an isolated incident.Trending will continue to be monitored for this device, incident issues, and causes.Attempt #1.07/01/2022 left a voice message for the customer for all items under the no information section.No response was received.07/01/2022 emailed the customer via microsoft outlook for all items under the no information section.No reply was received.

• 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: 14894023
• MDR Text Key: 303674970
• Report Number: 8030229-2022-02940
• 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: Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 06/12/2023

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: 06/06/2022
• Initial Date FDA Received: 07/01/2022
• Supplement Dates Manufacturer Received: 05/11/2023
• Supplement Dates FDA Received: 06/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/25/2013
• 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