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

Model Number CNS-6201A

Device Problems No Display/Image (1183); Display or Visual Feedback Problem (1184); Output Problem (3005)

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 central nurse's station (cns) was having issues with the display.They have 1 display working and the other is black.When they tap on the black display, it moves to the other display.It is unknown whether the device was in patient use.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.Concomitant medical device: attempt #1: 02/09/2024 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #2: 02/16/2024 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #3: 02/20/2024 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) was having issues with the display.They have 1 display working and the other is black.When they tap on the black display, it moves to the other display.It is unknown whether the device was in patient use.

Manufacturer Narrative

Details of the complaint: the biomedical engineer (bme) reported that the central nurse's station (cns) was having issues with the display.They have 1 display working and the other is black.When they tap on the black display, it moves to the other display.It is unknown whether the device was in patient use.Investigation conclusion: we were unable to confirm the reported issue.A definitive root cause could not be determined.But based on the available information the most probable root cause was potentially due to an incompatible resolution issue.Tech support sent the customer instructions on getting the display back up and working.Additionally sent a resolution guide in changing the resolution to see if that resolved the issue.However, the customer did not respond to all attempts made by nk to ensure the issue was resolved.The customer may have been able to resolve the issue on their own, without additional assistance from technical support.We have also identified several potential causes of display related issues, which are not limited to, and explained in further detail below: display failure or issues with display artifacts/bars - this failure may be caused by loose power cable, loose cable extender, defective usb port, defective graphic/video card, defective power supply, defective ac outlet, or defective display.Incompatible resolutions on monitors connected to the system via video splitters may also keep the cns software from being able to boot up or run correctly, which may require disconnecting video splitters.Reportable display symptom issues may include display blank, display black, resolution error, fuzzy screen (resolution settings) and/or color lines, blocking, partial, complete screen loss or touch key issues.A defective display can be caused by electronic failure, incorrect installation, environmental factors, physical damage, incompatibility of display device with cns unit or user error.Displays have individual power cables that plug directly into wall outlets.Each display is individually connected to the cns via a display cable.Resolution errors occur when displays that have incompatible resolutions or incorrect resolution settings are connected to the system.Resolution errors could lead to the boundaries of the screen being beyond the display monitor, leading to inaccessible tool bars or touchscreen options.This could lead to input or password issues.The cns device has native resolution of 1920x1200 pixels.Settings other than the default will cause resolution error.Device history: a serial number review of the reported device ((b)(6), 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.

Event Description

The biomedical engineer (bme) reported that the central nurse's station (cns) was having issues with the display.They have 1 display working and the other is black.When they tap on the black display, it moves to the other display.It is unknown whether the device was in patient use.

• 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: 18853166
• MDR Text Key: 337619938
• Report Number: 8030229-2024-04193
• 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-6201A
• Device Catalogue Number: PU-621RA
• Was Device Available for Evaluation?: No
• 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: 10/09/2015
• Supplement Dates FDA Received: 05/31/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/23/2015
• 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