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 Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/03/2020

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer (bme) reported that the central nurse's station (cns) display is showing a second image behind the first image and is overlapped and shifted.Making it difficult to monitor the screen.The shift causes the image to be extremely blurry.Nihon kohden (nk) technical support had them check the video cable connections and go through all the display configuration settings, but they were correct.They then power cycled the cns, but the issue persists.The biomed said the last time this issue occurred is when they did something with the kvm box.Nk tech support explained that we do not configure the kvm.However, the nk installation technician stated that the issue was the keyboard, video and mouse (kvm) extender might have drifted causing the cns touch screen display to become distorted, or out of focus.While on site about 6 months ago, he showed them how to correct it on a few cnss that needed adjustment.They called the install tech recently, and he was able to talk them through the process over the phone which corrected the issue.No patient harm 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.Additional device information: concomitant medical device field contains no information (ni), as attempts to obtain information were made, but not provided.

Event Description

The biomedical engineer (bme) reported that the central nurse's station (cns) display is showing a second image behind the first image and is overlapped and shifted.Making it difficult to monitor the screen.The shift causes the image to be extremely blurry.Nihon kohden (nk) technical support had them check the video cable connections and go through all the display configuration settings, but they were correct.They then power cycled the cns, but the issue persists.The biomed said the last time this issue occurred is when they did something with the kvm box.Nk tech support explained that we do not configure the kvm.However, the nk installation technician stated that the issue was the keyboard, video and mouse (kvm) extender might have drifted causing the cns touch screen display to become distorted, or out of focus.While on site about 6 months ago, he showed them how to correct it on a few cnss that needed adjustment.They called the install tech recently, and he was able to talk them through the process over the phone which corrected the issue.No patient harm reported.

Event Description

The biomedical engineer (bme) reported that the central nurse's station (cns) display is showing a second image behind the first image and is overlapped and shifted.Making it difficult to monitor the screen.The shift causes the image to be extremely blurry.Nihon kohden (nk) technical support had them check the video cable connections and go through all the display configuration settings, but they were correct.They then power cycled the cns, but the issue persists.The biomed said the last time this issue occurred is when they did something with the kvm box.Nk tech support explained that we do not configure the kvm.However, the nk installation technician stated that the issue was the keyboard, video and mouse (kvm) extender might have drifted causing the cns touch screen display to become distorted, or out of focus.While on site about 6 months ago, he showed them how to correct it on a few cnss that needed adjustment.They called the install tech recently, and he was able to talk them through the process over the phone which corrected the issue.No patient harm reported.

Manufacturer Narrative

Details of complaint: the biomedical engineer (bme) reported that the display on the central nurse's station (cns) was showing a second image behind the first image and was overlapped and shifted, making it difficult to monitor the vitals.No patient harm or injury was reported.Service requested / performed: troubleshooting.Investigation summary: the customer indicated that the shift caused the image to be blurry.The customer had verified that the video cable connections and the display configuration settings were correct.The customer indicated that the last time this issue had occurred was when they installed a new kvm.During follow up communication with the customer, it was indicated that the kvm extender may have drifted which has caused the cns display to be blurred.Nk assisted the customer through the process of correcting the issue.A review of the history of the serial number identified no further reports of the issue.Based on the available information, a definitive root cause could not be identified.However, it is likely that the kvm extender may have loosened due to human error.Users may have inadvertently pulled cables connected to the kvm which may have drifted or loosen the kvm.

• Brand Name: CNS-6801A
• Type of Device: CENTRAL MONITOR SYSTEM
• Manufacturer (Section D): NIHON KOHDEN CORPORATION; attn: shama mooman; shinjuku-ku; tokyo, 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 ; safety mgmt dept, quality mgmt; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 9876203
• MDR Text Key: 200805393
• Report Number: 8030229-2020-00185
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 03/24/2020,01/17/2023

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
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/24/2020
• Distributor Facility Aware Date: 03/03/2020
• Device Age: 31 MO
• Event Location: Hospital
• Date Report to Manufacturer: 03/24/2020
• Initial Date Manufacturer Received: 03/03/2020
• Initial Date FDA Received: 03/24/2020
• Supplement Dates Manufacturer Received: 01/12/2023
• Supplement Dates FDA Received: 01/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/14/2017
• 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