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 12/01/2023

Event Type  malfunction  

Manufacturer Narrative

Complaint summary: the biomedical engineer (bme) reported that the central nurse's station (cns) would not boot up to windows, it goes to an intel blue screen that reads "no operating system found" and has a hard drive failure message on the unit while monitoring patients.The bme tried swapping hard drives from one port to the other, but this did not resolve the problem.The bme removed the cns from use and put a known working cns in its place.No specific patient was impacted so no injury occurred.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.

Event Description

The biomedical engineer (bme) reported that the central nurse's station (cns) would not boot up to windows, it goes to an intel blue screen that reads "no operating system found" and has a hard drive failure message on the unit while monitoring patients.The bme tried swapping hard drives from one port to the other, but this did not resolve the problem.The bme removed the cns from use and put a known working cns in its place.No specific patient was impacted so no injury occurred.

Event Description

The biomedical engineer (bme) reported that the central nurse's station (cns) would not boot up to windows, it goes to an intel blue screen that reads "no operating system found" and has a hard drive failure message on the unit while monitoring patients.The bme tried swapping hard drives from one port to the other, but this did not resolve the problem.The bme removed the cns from use and put a known working cns in its place.No specific patient was impacted so no injury occurred.

Manufacturer Narrative

Complaint summary: on 12/01/2023, the biomed reported that the central nurse's station (cns), (pu-621ra, serial number: (b)(6)) would not boot up to windows and would go into an intel blue screen that displayed "no operating system found." the customer stated they were going to troubleshoot both hard drives and call back with results.The customer called back and confirmed the hdd error remained after troubleshooting and they do not want to purchase new replacements at the moment.They will replace the current cns with a spare (b)(6) cns they have to resolve the issue.There was patient involvement when the issue occurred, but no report of patient harm, no injury, nor any adverse event, due to the reported issue.Investigation summary: based on the troubleshooting performed by the biomed at the hospital, nk was able to confirm the reported issue was related to the hard disc drives failing.A definitive root cause could not be determined since the device and or hard disc drives were not sent into nk repair center.Based on the available information, the most probable root cause was caused by hdd failure.The customer performed troubleshooting and confirmed the hdds will need to be replaced.However, the customer decided they would not purchase new hdds for this cns and to resolve the issue they will replace the cns with a spare cns 6801 they have on site.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.In the event of an ungraceful 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: (b)(6)) shows one additional related complaint (from 2021).Complaint history review of the customer's account does not reveal trends for similar complaints.

• 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: 18384058
• MDR Text Key: 331505400
• Report Number: 8030229-2023-03969
• 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: 03/06/2024

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-6201A
• Device Catalogue Number: PU-621RA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/01/2023
• Initial Date FDA Received: 12/22/2023
• Supplement Dates Manufacturer Received: 03/05/2024
• Supplement Dates FDA Received: 03/06/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/03/2014
• 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