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 02/06/2024

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer (bme) reported that the recently had a go live with a new central nurse's station (cns), all other devices seem to be functioning just fine.This cns continuously reboots itself, but then will come back up and successfully launch the software.Then, once the cns has been running again it will reboot.This issue happened once earlier in the day.As the day went on, the cns was rebooting more frequently.Each time the cns reboots, the cns will beep 3 times.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.

Event Description

The biomedical engineer (bme) reported that the recently had a go live with a new central nurse's station (cns), all other devices seem to be functioning just fine.This cns continuously reboots itself, but then will come back up and successfully launch the software.Then, once the cns has been running again it will reboot.This issue happened once earlier in the day.As the day went on, the cns was rebooting more frequently.Each time the cns reboots, the cns will beep 3 times.No patient harm was reported.

Event Description

The biomedical engineer (bme) reported that the recently had a go live with a new central nurse's station (cns), all other devices seem to be functioning just fine.This cns continuously reboots itself, but then will come back up and successfully launch the software.Then, once the cns has been running again it will reboot.This issue happened once earlier in the day.As the day went on, the cns was rebooting more frequently.Each time the cns reboots, the cns will beep 3 times.No patient harm was reported.

Manufacturer Narrative

Details of the complaint: the biomedical engineer (bme) reported that the recently had a go live with a new central nurse's station (cns), all other devices seem to be functioning just fine.This cns continuously reboots itself, but then will come back up and successfully launch the software.Then, once the cns has been running again it will reboot.This issue happened once earlier in the day.As the day went on, the cns was rebooting more frequently.Each time the cns reboots, the cns will beep 3 times.No patient harm was reported.Investigation conclusion: the reported issue could not be duplicated.Upon evaluation from repair center, the unit booted up properly and monitored the bedside unit without any issues.The unit was tested for several days without any issues.Repair center found both hdds to be toshiba.They replaced the hdds and re-imaged them.A definitive root cause could not be determined but based on the available information, the most probable root cause was potentially caused by improperly seated network cable.An overview of the other potential startup related issues is listed below: startup and bootup errors, including "network service disconnected" and "monitor network service disconnect," may arise from issues with the ups (uninterruptible power supply) including damage to the cord, device, or area surrounding the ups plug, malfunction of the hdd components which may cause freezing at the bios or registration screen, issues with proper software registrations, malfunction of the wall ports, and improper seating of connection cables.Other issues that are known to cause freezing or startup errors are changing the font size in the settings menu, sudden shutdowns (power loss), faulty network switches, overheating (e.G., fans clogged with foreign material such as dust or debris or wear and tear resulting in the fan not operating as intended), and duplicate ip addresses."bootlooping" or continuous restarts of the cns may be caused by device driver issues, screen resolution errors, windows update issues or corrupt registry entries.Users with startup screens which are blue or black should restart the machine in safe mode to resolve issues.A black screen may indicate corruption of the disk guid partition table, while a blue screen may indicate a lack of free space in the system, memory problems, and hard drive faults.To ensure correct device function, users should ensure that devices are connected to power supplies.In the event of failure of uninterruptible power supply, users should verify devices are connected to alternate power sources.For connected devices that are incorrectly seated or connected to the data acquisition unit or other input unit, users may receive an "input unit failure" message.Users should re-seat the input unit and reinstate monitoring.Device history: a serial number review of the reported device (model: pu-681ra, serial number (b)(6)) does not reveal additional related complaints.Complaint history review of the customer's account does not reveal trends for similar complaints.The following fields contains no information (ni), as attempts to obtain information were made, but the information was not provided.A2 - a6 b6 - b7 d10 concomitant medical device attempt #1 03/01/2024 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #2 03/04/2024 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #3 03/06/2024 emailed customer via microsoft outlook for all items under the no information section.The customer responded back with complaint details, but they did not provide the patient and additional device information as requested.Additional information: b4 date of this report.D9 device available for evaluation.G3 date received by manufacturer.H2 if follow-up, what type?.H3 device evaluated by manufacturer.H6 event problem and evaluation codes.H10 additional manufacturer narrative.

• 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: 18853217
• MDR Text Key: 337527702
• Report Number: 8030229-2024-04153
• Device Sequence Number: 1
• Product Code: MHX
• 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: 05/31/2024

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/06/2024
• Initial Date FDA Received: 03/06/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/31/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2023
• 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