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

Model Number CNS-6801A

Device Problems Application Program Problem (2880); Unintended Application Program Shut Down (4032)

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

Event Date 02/12/2024

Event Type  malfunction  

Manufacturer Narrative

The nk project management manager reported that on 02/12 2:00 pm est that the central nurse's station (cns) at silver 9 started rebooting again and seemed to correct itself and has been operating normally since then.Then on 02/13, the biomedical engineer (bme) stated that the cns" was lagging" and that during the new set up their cns was responding slowly.There was a moment when the nurses would press the discharge button three times, and it would reboot the cns.The lagging issue is referring to the discharge issue.Tech support (ts) asked the bme if the nurses are still experiencing the delay in response, and they stated that everything was working as intended on the cns.The bme would like to know what happened.No patient harm was 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 contains no information (ni), as attempts to obtain information were made, but the information was not provided.Attempt #1 02/16/2024 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #2 03/06/2024 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #3 03/13/2024 emailed customer via microsoft outlook for all items under the no information section.No reply was received.

Event Description

The nk project management manager reported that on 02/12 2:00 pm est that the central nurse's station (cns) at silver 9 started rebooting again and seemed to correct itself and has been operating normally since then.Then on 02/13, the biomedical engineer (bme) stated that the cns" was lagging" and that during the new set up their cns was responding slowly.There was a moment when the nurses would press the discharge button three times, and it would reboot the cns.The lagging issue is referring to the discharge issue.Tech support (ts) asked the bme if the nurses are still experiencing the delay in response, and they stated that everything was working as intended on the cns.The bme would like to know what happened.No patient harm was reported.

Manufacturer Narrative

Details of the complaint: the nk project management manager reported that on (b)(6) 2:00 pm est that the central nurse's station (cns) at silver 9 started rebooting again and seemed to correct itself and has been operating normally since then.Then on (b)(6), the biomedical engineer (bme) stated that the cns" was lagging" and that during the new set up their cns was responding slowly.There was a moment when the nurses would press the discharge button three times, and it would reboot the cns.The lagging issue is referring to the discharge issue.Tech support (ts) asked the bme if the nurses are still experiencing the delay in response, and they stated that everything was working as intended on the cns.The bme would like to know what happened.No patient harm was reported.Investigation conclusion: log analysis for the cns performed and found that the cns was set up using a copied hard drive from another device.Nkc is not able to guarantee the functionality of the device due to being setup without the proper procedure.It was advised that the device be set up with the proper procedure.The root cause is likely related to improper device set up.

Event Description

The nk project management reported that on (b)(6) 2:00 pm est that the central nurse's station (cns) at silver 9 started rebooting again and seemed to correct itself and has been operating normally since then.Then on (b)(6), the biomedical engineer (bme) stated that the cns" was lagging" and that during the new set up their cns was responding slowly.There was a moment when the nurses would press the discharge button three times, and it would reboot the cns.The lagging issue is referring to the discharge issue.Tech support (ts) asked the bme if the nurses are still experiencing the delay in response, and they stated that everything was working as intended on the cns.The bme would like to know what happened.No patient harm 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; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 18899565
• MDR Text Key: 337799414
• Report Number: 8030229-2024-04164
• 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,Followup
• Report Date: 05/06/2024

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: 02/12/2024
• Initial Date FDA Received: 03/13/2024
• Supplement Dates Manufacturer Received: 04/18/2024
• Supplement Dates FDA Received: 05/06/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/23/2023
• 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: NI.; NI.