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

Model Number CNS-6801A

Device Problem Defective Component (2292)

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

Event Date 04/17/2023

Event Type  malfunction  

Event Description

The customer reported that the central nurse's station (cns) displayed an hdd port 1 error message.The customer swapped the drives and the error moved to hdd port 2 error message.There was no patient injury reported.

Manufacturer Narrative

The customer reported that the central nurse's station (cns) displayed an hdd port 1 error message.The customer swapped the drives and the error moved to hdd port 2 error message.The customer would like to replace the backup drive with a blank drive.The unit was not in patient use at the time.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 contain no information (ni), as attempts to obtain information were made, but not provided: attempt # 1: (b)(6) 2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: (b)(6) 2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 3 (b)(6) 2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 1: (b)(6) 2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: (b)(6) 2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 3 (b)(6) 2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 1: (b)(6) 2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: (b)(6) 2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 3 (b)(6) 2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 1: (b)(6) 2023 emailed the customer via microsoft outlook for device information: no reply was received.Attempt # 2: (b)(6) 2023 emailed the customer via microsoft outlook for device information: no reply was received.Attempt # 3 (b)(6) 2023 emailed the customer via microsoft outlook for device information: no reply was received.

Event Description

The customer reported that the central nurse's station (cns) displayed an hdd port 1 error message.The customer swapped the drives and the error moved to hdd port 2 error message.There was no patient injury reported.

Manufacturer Narrative

Details of complaint: the customer reported that the central nurse's station (cns) displayed an hdd port 1 error message.The customer swapped the drives and the error moved to hdd port 2 error message.The customer would like to replace the backup drive with a blank drive.The unit was not in patient use at the time.Investigation summary: the reported error message is expected to display after the device has exceeded 20,000 hrs of runtime.The hdd port error message on the cns occurs when the used hours of the hdd have exceeded 20,000 hrs.An hdd port error message prompts the user to check the condition of the hdds when it has exceeded 20,000 hrs.Of runtime.To mitigate the risks from hdd failures, the cns is designed with raid (redundant array of independent disks), so that if one hdd fails, another hdd can take over.There is no malfunction of the device.The following fields contain no information (ni), as attempts to obtain information were made, but not provided: attempt # 1: 04/26/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: 05/01/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 3 05/08/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 1: 04/26/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: 05/01/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 3 05/08/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 1: 04/26/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: 05/01/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 3 05/08/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 1: 04/26/2023 emailed the customer via microsoft outlook for device information: no reply was received.Attempt # 2: 05/01/2023 emailed the customer via microsoft outlook for device information: no reply was received.Attempt # 3 05/08/2023 emailed the customer via microsoft outlook for device information: no reply was received.Manufacturer references # (b)(4).

• 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; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 16939517
• MDR Text Key: 315473168
• Report Number: 8030229-2023-03503
• 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: 08/11/2023

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: 04/17/2023
• Initial Date FDA Received: 05/16/2023
• Supplement Dates Manufacturer Received: 08/09/2023
• Supplement Dates FDA Received: 08/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/17/2020
• 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