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

Model Number CNS-6801A

Device Problems Use of Device Problem (1670); Output Problem (3005)

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

Event Date 10/31/2023

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer (bme) reported that the device swapped bed id and ip addresses after they had admitted a patient.This has happened 2 times, and they were able to see it one of the two times.They said that the first time this happened was on october 16th and the 2nd time on october 31st.This has happened two times, but they have not been able to duplicate the issue, nor have they seen it happen again.After they discharged the patient, the devices swapped bed id and ip address around again.The two bed ip address that were given were: 172.016.020.143 pacu bsm 3500 172.16.20.113 ed bsm 6000 no patient harm was 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 device swapped bed id and ip addresses after they had admitted a patient.This has happened 2 times, and they were able to see it one of the two times.They said that the first time this happened was on october 16th and the 2nd time on october 31st.This has happened two times, but they have not been able to duplicate the issue, nor have they seen it happen again.After they discharged the patient, the devices swapped bed id and ip address around again.The two bed ip address that were given were: 172.016.020.143 pacu bsm 3500; 172.16.20.113 ed bsm 6000.No patient harm was reported.

Event Description

The biomedical engineer (bme) reported that the central nurse's station swapped the bed ids and ip addresses on two separate occasions, ((b)(6) 2023 and (b)(6) 2024), after admitting a patient.After discharging the patients, the devices swapped the bed ids and ip addresses back.No patient harm was reported.

Manufacturer Narrative

Details of complaint: the biomedical engineer (bme) reported that the central nurse's station swapped the bed ids and ip addresses, on two separate occasions ((b)(6) 2023 and (b)(6) 2024), after admitting a patient.No patient harm was reported.Investigation summary: the customer was not able to duplicate the issue and did not see it happen again.Once the patients were discharged, the devices swapped the bed ids and ip addresses back.The two bed ip addresses that were given were (b)(4).The logs from the bsms and the cnss locally filing the bsms were reviewed by nihon kohden corporate (nkc).The issue could not be confirmed by the logs and was presumed to be a misunderstanding by the customer.Nkc also found that the cns devices were not set up with the correct procedure and recommended re-installing the os using the correct procedure.During the investigation of the logs from each of the bedside monitors (bsm) and the cns, no history of the bed ids and/or the ip addresses having been swapped was found.Since the bsm-3500 does not have the transport function, it is supposed that the bsm swapping the bed id and/or the ip address would be very unlikely.The reported phenomenon is considered to be a misunderstanding by the customer.In addition, while reviewing the logs, it was found that the cns was set up by copying the hdd from another cns, which was of a different product type and was set up with the correct procedure.Therefore, the operation cannot be guaranteed.Nkc recommends replacing the cns with the one that was properly set up using the correct procedure for the os installation.The complaint could not be confirmed through the review of the device logs.A review of the customer's complaint history did not show trends for this issue and the device's serial number.Nk will continue to monitor and trend similar complaints.The following fields contains no information (ni), as attempts to obtain the information were made, but not provided: a2 - a6 b6 - b7 d10 attempt #1 11/21/2023 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #2 11/28/2023 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #3 12/01/2023 emailed customer via microsoft outlook for all items under the no information section.The customer responded, but did not provide the requested information.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.

• 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: 18253097
• MDR Text Key: 329575313
• Report Number: 8030229-2023-03919
• 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: 01/24/2024

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: 11/03/2023
• Initial Date FDA Received: 12/01/2023
• Supplement Dates Manufacturer Received: 01/18/2024
• Supplement Dates FDA Received: 01/24/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/08/2023
• 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