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

Model Number CNS-6801A

Device Problems Loss of Data (2903); Data Problem (3196)

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

Event Date 04/13/2023

Event Type  malfunction  

Event Description

The customer reported that the central nurse's station (cns) is removing room intermittently.There was no patient injury reported.

Manufacturer Narrative

The customer reported that the central nurse's station (cns) is removing room intermittently.It does have the patient in the room when removing the room.The cns was rebooted and it's now working correctly.Technical support (ts) informed the customer that as the system is working correctly, troubleshooting cannot be performed.There was no patient injury 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.The following fields contain no information (ni), as attempts to obtain information were made, but not provided: a2 - a6: 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: the customer replied by stating; no patient affected.B6 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: the customer replied by stating; no patient affected.B7 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: the customer replied by stating; no patient affected.D10 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: the customer replied by stating; no patient affected.

Event Description

The customer reported that the central nurse's station (cns) is removing room intermittently.There was no patient injury reported.

Manufacturer Narrative

Details of complaint: the customer reported that the central nurse's station (cns) is removing room intermittently.It does have the patient in the room when removing the room.The cns was rebooted and it's now working correctly.Technical support (ts) informed the customer that as the system is working correctly, troubleshooting cannot be performed.There was no patient injury reported.Investigation summary: a definitive root cause could not be determined from the device logs.Nkc developed a countermeasure to address this issue through the bsm-1700 software update to version 02-68.Review of the complaint device's serial number does not show other complaints.Review of the customer's complaint history does not show recurrence after the software update which was released 10/06/2023.The following fields contain no information (ni), as attempts to obtain information were made, but not provided: a2 - a6 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: the customer replied by stating; no patient affected.B6 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: the customer replied by stating; no patient affected.B7 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: the customer replied by stating; no patient affected.D10 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: the customer replied by stating; no patient affected.Manufacturer references (b)(4) follow up 001.

• 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: 16916598
• MDR Text Key: 315387752
• Report Number: 8030229-2023-03499
• 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: 12/14/2023

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: 04/13/2023
• Initial Date FDA Received: 05/11/2023
• Supplement Dates Manufacturer Received: 12/13/2023
• Supplement Dates FDA Received: 12/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/07/2020
• 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