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

Model Number CNS-6201A

Device Problems Display Difficult to Read (1181); Display or Visual Feedback Problem (1184); Output Problem (3005)

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

Event Date 03/23/2021

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer (bme) reported that the central nurse's station (cns) display will flicker making it difficult to read the information on the display.The customer stated that they have swapped in another display to see if it was an issue with the pc or the display.They stated that the flickering was still present on the new display.They customer stated they have also replaced the video cable with a known good one, and this did not resolve the reported issue.They later stated that this was not a one time incident and that they had been having problems with the flickering since before the biomed started working there according to the users.It happens every day, on different patients assigned to that cns.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.

Event Description

The biomedical engineer (bme) reported that the central nurse's station (cns) display will flicker making it difficult to read the information on the display.The customer stated that they have swapped in another display to see if it was an issue with the pc or the display.They stated that the flickering was still present on the new display.They customer stated they have also replaced the video cable with a known good one, and this did not resolve the reported issue.They later stated that this was not a one time incident and that they had been having problems with the flickering since before the biomed started working there according to the users.It happens every day, on different patients assigned to that cns.No patient harm reported.

Event Description

The biomedical engineer (bme) reported that the central nurse's station (cns) display will flicker making it difficult to read the information on the display.The customer stated that they have swapped in another display to see if it was an issue with the pc or the display.They stated that the flickering was still present on the new display.They customer stated they have also replaced the video cable with a known good one, and this did not resolve the reported issue.They later stated that this was not a one time incident and that they had been having problems with the flickering since before the biomed started working there according to the users.It happens every day, on different patients assigned to that cns.No patient harm reported.

Manufacturer Narrative

Details of complaint: on 03-23-2021, the customer reported that the central nurse's station (cns) display will flicker making it difficult to read the information on the display.The customer stated that they have swapped in another display to see if it was an issue with the pc or the display.They stated that the flickering was still present on the new display.They customer stated they have also replaced the video cable with a known good one, and this did not resolve the reported issue.Qa asked for patient and additional concomitant device information, but it was not provided.However, they stated that this was not a onetime incident; and they had been having problems with the flickering since before the biomed started working there according to the users.It happens every day, on different patients assigned to reported cns.Investigation conclusion: the customer sent the unit in for repair and the reported unit was received at repair center (rc).The unit was cleaned and decontaminated.The model, serial number, and all labels were verified.The rc technician (tech) was not able to duplicate the reported problem of cns flickering.The rc tech found out that the found both hard disk drives (hdd) were out of warranty since 01/2016 and software version was 02-10 which was very old.The rc tech recommended to replace hdd as a precautionary step.The rc tech replaced the hard drives and re-imaged the device to software version 02-40 to resolve the reported problem.The unit was tested per the operator's/ service manual and the results were recorded on the attached maintenance check sheet.The unit completed 24 hours of extended testing and operates to the manufacturer's specifications.The repaired unit was sent back to service stock in warehouse to send it to customer.Attempt #1: 03/24/2021 emailed customer via microsoft outlook for all items under the no information section.The customer responded back with additional complaint details, but they did not provide patient information.Additional device information: d10: concomitant medical device field contains no information (ni), as attempts to obtain information were made, but not provided.Attempt #1: 03/24/2021 emailed customer via microsoft outlook for all items under the no information section.The customer responded back with additional complaint details, but they did not provide additional device information.

Event Description

The biomedical engineer (bme) reported that the display on the central nurse's station (cns) would frequently flicker, making it difficult to read the information on the display.Swapping in another display and replacing the video cable with a known good one did not resolve the issue.No patient harm was reported.

Manufacturer Narrative

Details of complaint: the biomedical engineer (bme) reported that the display on the central nurse's station (cns) would frequently flicker, making it difficult to read the information on the display.Swapping in another display and replacing the video cable with a known good one did not resolve the issue.No patient harm was reported.Investigation summary: the cns was evaluated by nihon kohden america (nka).The reported flickering phenomenon could not be duplicated.No issues were observed.Separately, two hard drives were replaced as preventative maintenance.This is not related to the reported flickering issue.Hard drives are replaced every two years or 20,000 hours of use.Since the flickering could not be duplicated, the root cause could not be determined.There were no failures with the display units, the video cables, the main processing units or other components.A review of the service history for this hospital was conducted to determine if similar flickering phenomena had been reported.There is no history of display flickering.

• 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: 11708234
• MDR Text Key: 280584396
• Report Number: 8030229-2021-00232
• 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,Followup
• Report Date: 05/04/2023

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/23/2021
• Initial Date FDA Received: 04/22/2021
• Supplement Dates Manufacturer Received: 07/14/2021; 05/03/2023
• Supplement Dates FDA Received: 08/09/2021; 05/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/22/2013
• 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