MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION CNS-6801A; CENTRAL MONITOR SYSTEM

Model Number CNS-6801A

Device Problems Display or Visual Feedback Problem (1184); Poor Quality Image (1408); Output Problem (3005)

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

Event Date 06/28/2021

Event Type  malfunction  

Manufacturer Narrative

The nurse reported that the central nurse's station (cns) display was giving off a yellow hue, and the lines and wording on the application appeared blurry and was very hard to read.Nihon kohden technical support (tech support) instructed the nurse to contact the biomed as it could be an issue with a dvi cable.The biomed responded that the rbg setting on the kvm receiver used with the cns was adjusted to resolve the issue.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 attempts to obtain information were made, but not provided.Attempt #1: (b)(6) 2021 emailed customer via (b)(4) for all items under the no information section.The customer responded back with complaint details, but they did not provide the patient and additional device information that was requested.Additional device information: concomitant medical device field contains no information (ni), as attempts to obtain information were made, but not provided.Attempt #1: (b)(6) 2021 emailed customer via (b)(4) for all items under the no information section.The customer responded back with complaint details, but they did not provide the patient and additional device information that was requested.

Event Description

The nurse reported that the central nurse's station (cns) display was giving off a yellow hue, and the lines and wording on the application appeared blurry and was very hard to read.Nihon kohden technical support (tech support) instructed the nurse to contact the biomed as it could be an issue with a dvi cable.The biomed responded that the rbg setting on the kvm receiver used with the cns was adjusted to resolve the issue.No patient harm was reported.

Manufacturer Narrative

Details of complaint: the nurse reported that the display on the central nurse's station (cns) was giving off a yellow hue, and the lines and text in the application appeared blurry, making it very hard to read.The biomedical engineer (bme) later reported to technical support (ts) that the rbg setting on the kvm receiver, used with the cns, was adjusted to resolve the issue.No patient harm was reported.Investigation summary: ts advised the caller to have a biomedical technician look into the video cable and call nihon kohden for further troubleshooting.The customer later explained the issue was resolved by adjusting settings on an external device, the kvm receiver.The kvm receiver is a device that relays video, keyboard, and mouse signals between the cns main unit and the output devices.This receiver is not part of the cns device.The cns continued to function as intended.If the user had been using this kvm receiver, it is unknown as to why the settings had changed.The service history for this cns shows no history of display issues.There was no indication of a device malfunction, and no recurrence history for this device.

Event Description

The nurse reported that the display on the central nurse's station (cns) was giving off a yellow hue, and the lines and text in the application appeared blurry, making it very hard to read.The biomedical engineer (bme) later reported to technical support (ts) that the rbg setting on the kvm receiver, used with the cns, was adjusted to resolve the issue.No patient harm was reported.

• Brand Name: CNS-6801A
• 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: 12242702
• MDR Text Key: 264085981
• Report Number: 8030229-2021-01430
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 04931921131640
• UDI-Public: 04931921131640
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/08/2023

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-6801A
• Device Catalogue Number: PU-681RA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/28/2021
• Initial Date FDA Received: 07/28/2021
• Supplement Dates Manufacturer Received: 05/03/2023
• Supplement Dates FDA Received: 05/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/21/2020
• 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