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

Model Number CNS-6801A

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 11/30/2021

Event Type  malfunction  

Event Description

The biomedical engineer (bme) reported that the video splitter video out has stopped being displayed on the remote displays of the central nurse's station (cns).They stated that they have narrowed the issue to the power supply by swapping in a working power supply and the video started working again.Qa contacted the customer to confirm if this remote display was mirroring the main screen to see if all patients were being monitored on the main screen, or if it was monitoring different patients than what was being monitored on the main cns screen.The customer has been unresponsive.No patient harm was reported.

Manufacturer Narrative

Details of complaint: the biomedical engineer (bme) reported that the aten video splitter had stopped working, which caused video to stop displaying on the remote displays.The customer was able to identify that the power supply for the video splitter was defective.They swapped in a working power supply, which resolved the issue.Nihon kohden contacted the customer to confirm whether this remote display was mirroring the main screen to see if all patients were being monitored on the main screen.However, the customer was unresponsive.No patient harm or injury was reported.Investigation summary: the customer was able to identify that the power supply for the video splitter was defective and would order a new video splitter kit to resolve the issue.A review of the history of the serial number identified no further reports on the issue, suggesting that the issue had been resolved.Based on the available information, the most probable cause of the issue is the failure of a 3rd party component (video splitter).The issue was caused by failure of a video splitter.There was no malfunction of the cns.Additional information: b4 date of this report.G3 date received by manufacturer.G6 type of report.H2 if follow-up, what type? h6 event problem and evaluation codes.H10 additional manufacturer narrative.

Event Description

The biomedical engineer (bme) reported that the aten video splitter had stopped working, which caused video to stop displaying on the remote displays.The customer was able to identify that the power supply for the video splitter was defective.They swapped in a working power supply, which resolved 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: 13115791
• MDR Text Key: 284889861
• Report Number: 8030229-2021-02320
• 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: 04/04/2023

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-6801A
• Device Catalogue Number: PU-681RA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/30/2021
• Initial Date FDA Received: 12/29/2021
• Supplement Dates Manufacturer Received: 06/27/2022
• Supplement Dates FDA Received: 04/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/04/2018
• 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