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)

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

Event Date 06/08/2022

Event Type  malfunction  

Manufacturer Narrative

The customer reported that the central nurse's station (cns) primary display "flashed" a few times then it went blank and were not able to monitor the patients on the affected screen until they moved those affected patients onto a different cns to continue monitoring them.No patient harm was reported.Nihon kohden technician had the customer check the monitored bed setting tab on the cns and it still showed a second display connected but the display that is blank is the primary display.Therefore, the customer is not able to access the windows start menu to check if windows was recognizing the other screen.Nihon kohden technician advised the customer to have their biomedical department to do further troubleshooting with the system on-site.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 customer reported that the central nurse's station (cns) primary display "flashed" a few times then it went blank, and the medical staff was not able to monitor those patients on the affected screen.Nihon kohden technician assisted the customer with setting up another cns to continue monitoring the patients.No patient harm was reported.Nihon kohden technician had the customer check the monitored bed setting tab on the cns and it still showed a second display connected but the display that is blank is the primary display.Therefore, the customer is not able to access the windows start menu to check if windows was recognizing the other screen.Nihon kohden technician advised the customer to have their biomedical department to do further troubleshooting with the system on-site.

Event Description

The customer reported that the primary display on the central nurse's station (cns) "flashed" a few times then went blank.The medical staff was unable to monitor patients on the affected screen.No patient harm was reported.

Manufacturer Narrative

Details of complaint: the customer reported that the primary display on the central nurse's station (cns) "flashed" a few times then went blank.The medical staff was unable to monitor patients on the affected screen.Technical support (ts) had the customer check the monitored bed settings tab on the cns, which continued to show that the second display was connected, but the primary display was still blank.The customer was not able to access the windows start menu to check to see whether windows was recognizing the other screen.Ts advised that the customer have their biomedical department to do further troubleshooting with the system on-site.No patient harm was reported.Investigation summary: the troubleshooting was not completed since the customer needed involvement of their biomedical technician.Further information was not provided; therefore, the cause of the display issue cannot be determined.Display issues are typically related to a bad cable connection, power supply, and cns settings.This device was installed on 07/24/2016 with no prior history of display issues.There was no indication of a device malfunction.There is no recurrence history for this device.The following fields contains no information (ni), as attempts to obtain the information were made, but not provided.A2 - a6 b6 b7 attempt #1 07/05/2022 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #2 07/06/2022 emailed customer via microsoft outlook for all items under the no information section.No reply was received.

• 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: 14934785
• MDR Text Key: 304047047
• Report Number: 8030229-2022-02939
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/13/2023

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: 06/08/2022
• Initial Date FDA Received: 07/06/2022
• Supplement Dates Manufacturer Received: 05/19/2023
• Supplement Dates FDA Received: 06/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2015
• 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