MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION CNS-9700A; CENTRAL MONITOR SYSTEM

Model Number CNS-9700A

Device Problem Display or Visual Feedback Problem (1184)

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

Event Date 12/08/2021

Event Type  malfunction  

Manufacturer Narrative

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) was rebooted and when it came back up, all the bed-tiles displayed the message "system failure".No patient harm was reported.Nihon kohden technician requested the bme to press the silence alarm button on each of the bedside monitors and when they did that resolved the failure message on the cns.Nk technician advised the bme that the device has reached the end of life expectancy.

Event Description

The biomedical engineer (bme) reported that after the central nurse's station (cns) was rebooted, a "system failure" error message was displayed on all bed-tiles.No patient harm was reported.

Manufacturer Narrative

Details of complaint: the biomedical engineer (bme) reported that after the central nurse's station (cns) was rebooted, a "system failure" error message was displayed on all bed-tiles.No patient harm was reported.Investigation summary: the reported issue of a system failure error message on all tiles was resolved by silencing the alarms on each individual bed tile.As the issue occurred after a cns reboot, it is likely that the cause of the issue is related to the cns start up process.The cns was installed in 2007 with no history of servicing.It is likely that the hard drives of the cns were starting to fail as a result of wear and tear.The hdds are electronic components that may deteriorate through time and may wear from continual use.Possible causes of failure include mechanical failure from improper use/handling, corruption of the files from abnormal shutdowns, viruses, or power issues.Other possible causes of the issue are power surges/interruptions and wear and tear.Any events that involve fluctuations and changes in the voltage such as power outages and generator tests may damage the hdds.Fluid intrusion, dust accumulation, or a lack of maintenance on fans, air intakes, and other components may lead to overheating of the hard drive and subsequent failure.When hard drives fail, this failure can manifest in different ways.There can be an error message (e.G., "hdd access error," "ssd access error," "ssdx error," "threshold breach"), or the device may reboot, display a blue failure screen, or the device screen could "freeze." the unit may sometime then restart, or the device may need to have the hard drive replaced.Sometimes the unit can be rebuilt by the backup disk (i.E., the system has redundant array of independent disks (raid), which puts multiple hard drives together to improve performance).Nk will continue to monitor and trend similar complaints.Due to the age of the device and lack of servicing history, the cns was likely failing due to hdd failure as a result of wear and tear.The following fields contain no information (ni), as attempts to obtain information were made, but not provided: attempt # 1: 12/14/2021 emailed the customer via microsoft outlook for all information in the ni list: no reply was received.Attempt # 2: 12/28/2021 emailed the customer via microsoft outlook for all information in the ni list: no reply was received.Attempt # 3: 12/30/2021 emailed the customer via microsoft outlook for all information in the ni list: no reply was received.Additional device information: d10 concomitant medical device: the following devices were used in conjunction with the cns however, the model and serial numbers are listed as no information (ni) as attempts to obtain the information were made, but not provided: bedside monitor (bsm): model #: ni.Serial #: ni.Device manufacturer data: ni.

• Brand Name: CNS-9700A
• 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; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 13122690
• MDR Text Key: 285043457
• Report Number: 8030229-2021-02277
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 04931921000663
• UDI-Public: 04931921000663
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K023475
• 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: 07/26/2023

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-9700A
• Device Catalogue Number: MU-971RA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/08/2021
• Initial Date FDA Received: 12/30/2021
• Supplement Dates Manufacturer Received: 07/24/2023
• Supplement Dates FDA Received: 07/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/28/2006
• 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: BSM; BSM