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

Model Number CNS-6201A

Device Problem Computer Software Problem (1112)

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

Event Date 12/20/2023

Event Type  malfunction  

Event Description

The biomedical engineer (bme) reported that the central nurse's station (cns) was not booting up.The bme swapped the hard disc drives but the unit is still not booting up.No patient harm was reported.Nihon kohden technician advised the bme to purchase new hard drives.

Manufacturer Narrative

The biomedical engineer (bme) reported that the central nurse's station (cns) was not booting up.The bme swapped the hard disc drives but the unit is still not booting up.No patient harm was reported.Nihon kohden technician advised the bme to purchase new hard drives.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 contain no information (ni), as attempts to obtain the information were made, but not provided: a2: a6 b6: b7.D10: attempt # 1: 12/21/2023 emailed the customer via microsoft outlook for all information in the ni list above: no reply was received.Attempt # 2: 01/12/2024 emailed the customer via microsoft outlook for all information in the ni list above: no reply was received.Attempt # 3: 01/15/2024 emailed the customer via microsoft outlook for all information in the ni list above: no reply was received.

Manufacturer Narrative

Incident summary: on 12/20/2023, the biomed reported that the central nurse's station (cns), (model: pu-621ra, serial number (b)(6) would not boot up.The customer tried to swap the hard drives, but the issue persisted and would not boot up.It is unknown if there was patient involvement when the issue occurred, but there is no report of patient harm, no injury, nor any adverse event, due to the reported issue.The customer purchased brand new configured hard drives to resolve the issue.Investigation summary: the customer purchased brand new configured hard drives and installed them in the pu-621ra serial number (b)(6) to resolve the issue, therefore nk was able to confirm the reported issue.However, a definitive root cause could not be determined.But based on the available information, the most probable root cause was due to failing hard drives.An overview of the other potential boot up/hdd related issues are 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-621ra, serial number (b)(6) does not reveal additional related complaints and review of this devices warranty status shows that it has exceeded its warranty period.Complaint history review of the customer's account does not reveal trends for similar complaints.Nk will continue to monitor and trend similar complaints.The following fields contain no information (ni), as attempts to obtain the information were made, but not provided: d10 attempt # 1: 12/21/2023 emailed the customer via microsoft outlook for all information in the ni list above: no reply was received.Attempt # 2: 01/12/2024 emailed the customer via microsoft outlook for all information in the ni list above: no reply was received.Attempt # 3: 01/15/2024 emailed the customer via microsoft outlook for all information in the ni list above: no reply was received.Additional information: b4: date of this report.G3: date received by manufacturer.G6: type of report.H2: if follow-up, what type? h6: event problem and evaluation codes.H11: additional manufacturer narrative.

Event Description

The biomedical engineer (bme) reported that the central nurse's station (cns) was not booting up.The bme swapped the hard disc drives but the unit is still not booting up.No patient harm was reported.Nihon kohden technician advised the bme to purchase new hard drives.

• 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; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 18515185
• MDR Text Key: 333539017
• Report Number: 8030229-2024-04005
• 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: 03/25/2024

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-6201A
• Device Catalogue Number: PU-621RA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/20/2023
• Initial Date FDA Received: 01/15/2024
• Supplement Dates Manufacturer Received: 03/22/2024
• Supplement Dates FDA Received: 03/25/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/12/2016
• 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.