MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION CNS-6201A; CENTRAL MONITOR SYSTEM

Model Number CNS-6201A

Device Problems Output Problem (3005); Data Problem (3196); Patient Data Problem (3197)

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

Event Date 12/20/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(6) reported that the patient was discharged and readmitted, so patient data was missing from 2:45 pm to 4:00 pm.They also stated patient data is missing for another patient.It is unclear how they were discharged.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.The following fields contains no information (ni), as attempts to obtain information were made, but the information was not provided.D10 concomitant medical device.Attempt #1 12/28/2023 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #2 01/17/2023 emailed customer via microsoft outlook for all items under the no information section.No reply was received.

Event Description

(b)(6) reported that the patient was discharged and readmitted, so patient data was missing from 2:45 pm to 4:00 pm.They also stated patient data is missing for another patient.It is unclear how they were discharged.No patient harm was reported.

Manufacturer Narrative

Details of complaint: the biomedical engineer (bme) reported that the patient was discharged from the central nurse's station (cns) then readmitted, so patient data was missing from 2:45 pm to 4:00 pm.It is unclear how they were discharged.No patient harm was reported.Investigation summary: as the reported device was not sent in for evaluation, a definitive root cause cannot be determined.Nk technical support sent the customer clear instructions on how to pull the event logs for investigation.However, a lot of time has passed, and the originator of this reported no longer works at the facility and no other staff knows of this issue, so they requested that the ticket be closed.Based on the available information, it is likely the issue of missing full disclosure data could have been caused by power issues, improper workflow, or an unstable network connection.There is no evidence that the device malfunctioned during this reported time.As per the cns-6201 operator's manual the possible causes of the historical data (e.G., full disclosure, recall, or tabular trend data) not being displayed on the cns are power issues with equipment communicating with the cns (if the bedside monitor is turned off, it will not relay vital signs), if the waveform in question is not being saved to the bsm (e.G., due to waveform shape (sawtooth) or signal noise), if the required parameter is not selected for monitoring (settings), if a patient is accidentally discharged, or lead issues.If lead issues are contributing to the problem, it could be due to a faulty lead, the lead being poorly placed, or the incorrect lead for the vital sign might be in use.If a time hop or time sync issue occurs while viewing full disclosure, possible causes can include network issues, damaged ethernet cables or improper / incomplete seating of the ethernet cable in the port.Common solutions for time issues and other problems related to full disclosure are power cycling the bsm/cns and checking the ethernet cable and connection."data cannot be read" errors may occur when viewing in full disclosure as a result of local bedsides not being filed, waveform settings being improperly selected or stored, and issues with the hdd functioning properly.Settings issues may also occur whereby full disclosure settings return to default user settings.The causes for this may be ungraceful exits, user education, power outages, power surges, or user-selected settings.Additionally, cns systems may need to be rebooted to ensure proper historical data visibility.A serial number review of the reported device (model: pu-621ra, sn: (b)(6)) does not reveal additional related complaints.A complaint history review of the customer's account does not reveal trends for similar complaints.Nk will continue to monitor and trend similar complaints.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.H11 additional manufacturer narrative.

Event Description

The biomedical engineer (bme) reported that the patient was discharged from the central nurse's station (cns) then readmitted, so patient data was missing from 2:45 pm to 4:00 pm.It is unclear how they were discharged.No patient harm was reported.

• 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; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 18540913
• MDR Text Key: 333542836
• Report Number: 8030229-2024-04018
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2024
• 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
• Date Manufacturer Received: 03/20/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/02/2014
• 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