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 01/05/2022

Event Type  malfunction  

Event Description

The biomedical engineer (bme) reported that they are having display issues with the central nurse's station (cns).They can see that the secondary display is getting power, but it is just no showing any video on it.They are using a kvm to connect the cns tower to the 2 displays.He said that they verified that the secondary display works because they can move the video connection from the primary display dvi cable to the secondary and they see that they get video.No patient harm was reported.

Manufacturer Narrative

The biomedical engineer (bme) reported that they are having display issues with the central nurse's station (cns).They can see that the secondary display is getting power, but it is just no showing any video on it.They are using a kvm to connect the cns tower to the 2 displays.He said that they verified that the secondary display works because they can move the video connection from the primary display dvi cable to the secondary and they see that they get video.No patient harm was reported.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 an attempt to obtain the information were made, but none were provided.Attempt #1: (b)(6) 2021 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #2: (b)(6) 2022 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #3: (b)(6) 2022 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Additional device information: concomitant medical device: the following devices were being used in conjunction with the cns, but model and serial number information was noted as no information (ni), as attempts to obtain information were made but information was not provided.Attempt #1: (b)(6)2021 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #2: (b)(6) 2022 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #3: (b)(6) 2022 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 display on the central nurse's station (cns) was not showing video, even though it was getting power to it.No patient harm was reported.

Manufacturer Narrative

Details of complaint: the biomedical engineer (bme) reported that the secondary display on the central nurse's station (cns) was not showing video, even though it was getting power to it.No patient harm was reported.Investigation summary: as the reported device was not returned for evaluation, the reported issue could not be duplicated nor confirmed.As such, a root cause cannot be determined.Initially the customer reported that their secondary display was not receiving any video inputs.The customer planned to swap out the kvm to resolve that issue.At a later date, the customer reported that the display started to intermittently flicker.It was reported that the issue was isolated to the cns itself as the customer was able to test multiple working displays, which duplicated the issue.Follow up attempts made by nihon kohden technical support to resolve the issue were unanswered.In a later ticket (b)(4) for the same device reporting of display issues with their secondary monitor, it was discovered that the customer did not enable the secondary monitor in windows.It is likely that this event is related to the later event which was resolved after changing the settings in windows.

• 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; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 13453421
• MDR Text Key: 293282917
• Report Number: 8030229-2022-02432
• 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: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 05/15/2023

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-6201A
• Device Catalogue Number: PU-621RA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/05/2022
• Initial Date FDA Received: 02/04/2022
• Supplement Dates Manufacturer Received: 05/12/2023
• Supplement Dates FDA Received: 05/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/08/2014
• 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