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

Model Number CNS-6201A

Device Problems Computer Software Problem (1112); No Display/Image (1183)

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

Event Date 10/12/2023

Event Type  malfunction  

Manufacturer Narrative

Details of complaint: the biomedical engineer (bme) reported that the central nurse's station (cns) is freezing and going to a blue screen saying "your comupter ran into a problem".The bme said he tried to reboot the cns multiple times and sometimes it will make it into windows but then it will freeze and they are unable to do anything else.The bme stated that they had recently replaced the hard disc drives (hdd's).This cns is being sent into nk repair center.No patient harm was reported as they can still monitor patients on a remote nursing station (rns) at the time of the event.Repair service: the device was received to nihon kohden repair center (nkrc) and was found to have a lot of dust inside the unit.No physical damage or fluid intrusions found inside the unit.Nkrc verified the reported problem and found the cns has a paging file error.To resolve this issue, the hard drives were re-imaged.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 10/25/2023 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #2 11/07/2023 emailed 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 central nurse's station (cns) is freezing and going to a blue screen saying "your comupter ran into a problem".The bme said he tried to reboot the cns multiple times and sometimes it will make it into windows but then it will freeze and they are unable to do anything else.The bme stated that they had recently replaced the hard disc drives (hdd's).This cns is being sent into nk repair center.No patient harm was reported as they can still monitor patients on a remote nursing station (rns) at the time of the event.

Manufacturer Narrative

Details of complaint: the biomedical engineer (bme) reported that the central nurse's station (cns) is freezing and going to a blue screen saying "your comupter ran into a problem".The bme said he tried to reboot the cns multiple times and sometimes it will make it into windows but then it will freeze and they are unable to do anything else.The bme stated that they had recently replaced the hard disc drives (hdd's).This cns is being sent into nk repair center.No patient harm was reported as they can still monitor patients on a remote nursing station (rns) at the time of the event.Repair service: the device was received to nihon kohden repair center (nkrc) and was found to have a lot of dust inside the unit.No physical damage or fluid intrusions found inside the unit.Nkrc verified the reported problem and found the cns has a paging file error.To resolve this issue, the hard drives were re-imaged.Investigation summary: root cause analysis: the reported issue was confirmed and duplicated.A definitive root cause could not be determined.But upon further investigation from repair center, they discovered the device had a paging file error.The hdd on the device required reformatting to factory default to clear any corrupted files.Once the hdd was reimaged the unit was ready to be shipped back to the customer, to resolve the issue.An overview of the other potential boot looping/startup related issues are 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.Bootup/startup issues are usually discovered at startup and are therefore unlikely to cause patient harm.The issues are immediately evident to technicians who can then choose an alternative monitoring device.The device may enter a boot loop or fail to start up due to sudden power outage or other loss of power; these failures do not indicate a failure of the device but rather a response to environmental factors and do not require a capa.In the event of an ungrateful exit which is often caused by sudden power loss or outage, users should reboot the device.Device history: a serial number review of the reported device (pu-621ra, serial number 1503) 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 an attempt to obtain the information was made, but not provided.Attempt #1 10/25/2023 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #2 11/07/2023 emailed 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 central nurse's station (cns) is freezing and going to a blue screen saying "your comupter ran into a problem".The bme said he tried to reboot the cns multiple times and sometimes it will make it into windows but then it will freeze and they are unable to do anything else.The bme stated that they had recently replaced the hard disc drives (hdd's).This cns is being sent into nk repair center.No patient harm was reported as they can still monitor patients on a remote nursing station (rns) at the time of the event.

• 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: 18086676
• MDR Text Key: 327649746
• Report Number: 8030229-2023-03872
• 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: 01/17/2024

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/12/2023
• Initial Date FDA Received: 11/07/2023
• Supplement Dates Manufacturer Received: 01/16/2024
• Supplement Dates FDA Received: 01/17/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/08/2016
• 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