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

Model Number CNS-6801A

Device Problems Display or Visual Feedback Problem (1184); Output Problem (3005); No Visual Prompts/Feedback (4021)

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

Event Date 09/09/2023

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer (bme) reported that they have 2 central nurse's stations (cnss) watching the 5th floor (icu).They have one cns on 5th floor which is remotely filing and room 511 was not in the cns tile and dropped off the tile at some time.Also, room 528 lost the ecg waveform but still had spo2 and heart rate (hr) information.Tech support (ts) had the bme stop and restart monitoring room 511 and that did nothing.They rebooted the unit.After the first reboot, they could see waveforms in room 528.At that point, the bme stopped monitoring 511 and remonitored it, and they could then see spo2 and hr but no waveform.The cns was rebooted for the 2nd time, and they could see all the information this time.The 2nd reboot resolved all their issues.They have another cns in their telemetry room (6th floor) which is locally filing and could see all patient information in the tiles.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 are not applicable (na) to the mdr report: b2.D4 lot number & expiration.D6a - d6b.D7b.F1 - f14.G4 device bla number.G5.G7.H2.H7.H9.The following fields contains no information (ni), as attempts to obtain information were made, but the information was not provided.A2 - a6.B6 - b7.D10 concomitant medical device.Attempt #1 (b)(6) 2023 emailed customer via microsoft outlook for all items under the no information section.The customer responded back with complaint details, but they did not provide the patient and additional device information as requested.

Event Description

The biomedical engineer (bme) reported that they have 2 central nurse's stations (cnss) watching the 5th floor (icu).They have one cns on 5th floor which is remotely filing and room 511 was not in the cns tile and dropped off the tile at some time.Also, room 528 lost the ecg waveform but still had spo2 and heart rate (hr) information.Tech support (ts) had the bme stop and restart monitoring room 511 and that did nothing.They rebooted the unit.After the first reboot, they could see waveforms in room 528.At that point, the bme stopped monitoring 511 and remonitored it, and they could then see spo2 and hr but no waveform.The cns was rebooted for the 2nd time, and they could see all the information this time.The 2nd reboot resolved all their issues.They have another cns in their telemetry room (6th floor) which is locally filing and could see all patient information in the tiles.No patient harm was reported.

Manufacturer Narrative

Details of the complaint: the biomedical engineer (bme) reported that they have 2 central nurse's stations (cnss) watching the 5th floor (icu).They have one cns on 5th floor which is remotely filing and room 511 was not in the cns tile and dropped off the tile at some time.Also, room 528 lost the ecg waveform but still had spo2 and heart rate (hr) information.Tech support (ts) had the bme stop and restart monitoring room 511 and that did nothing.They rebooted the unit.After the first reboot, they could see waveforms in room 528.At that point, the bme stopped monitoring 511 and remonitored it, and they could then see spo2 and hr but no waveform.The cns was rebooted for the 2nd time, and they could see all the information this time.The 2nd reboot resolved all their issues.They have another cns in their telemetry room (6th floor) which is locally filing and could see all patient information in the tiles.No patient harm was reported.Investigation conclusion: a definitive root cause for both issues could not be determined from the troubleshooting and resolution details.A similar complaint for the dropped tile issue was investigated under 300331182 and other where possible causes were determined to be user error when using the wlan transport function for patient transfers, loss of network connection while using wlan transport, or loose connection of the input unit with the main unit bsm.The bsm operator's manual and user guides includes instructions for performing patient transfers and using wlan transport.Loss of wireless network connection during transport can be due to an unstable network environment at the customer site.Loose connection of the input unit with the main unit may cause incomplete data communication to the cns.Nkc also developed a countermeasure for this issue in the bsm-1700 software version 02-68 which was released on 10/06/2023.Review of the complaint device's serial number and customer complaint history does not show recurrence or other similar complaints for the dropped tile issue.Possible causes of the cns not showing waveforms while still showing numeric values may include lack of maintenance or hardware component issues such as hdd corruption or failure, which can lead to data processing issues.Hard drive corruption or failure can occur through physical damage from user mishandling, electrical damage from outages or surges, or wear-and-tear which depends on device age and frequency of use.Similar complaints for this issue were found under tickets (b)(4).Under ticket (b)(4) it was reported that the ecg waveforms would intermittently drop from the cns and this was resolved after rebooting the cns.The cns operator's manual states to restart the device once every 3 months to avoid operation issues.Under ticket (b)(4), it was reported that numerics and waveforms dropped intermittently from the cns and this was investigated by nkc where a definitive root cause could not be determined from the device logs but possible cause was likely related to corruption of the os since there was a history of forced shutdown and file crashes.Under ticket (b)(4) the cns was also evaluated by nk repair center who could not duplicate the complaint but found that the device had been initialized to factory settings.The hard drives were replaced and the software was reinstalled to repair this device.Review of the current complaint device's serial number does not show recurrence but shows 1 similar complaint under ticket (b)(4) where it was reported that the review data showed numeric values and no waveforms, and the issue resolved spontaneously.The complaint device is 5 years old and does not have any history for hdd replacements.The cns operator's manual recommends replacement of the hdds every 2 years.Due to the age of the device, wear-and-tear of hardware components may be a contributing factor to this issue.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: 09/11/2023 emailed customer via microsoft outlook for all items under the no information section.The customer responded back with complaint details, but they did not provide the patient and additional device information as requested.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 they have 2 central nurse's stations (cnss) watching the 5th floor (icu).They have one cns on 5th floor which is remotely filing and room 511 was not in the cns tile and dropped off the tile at some time.Also, room 528 lost the ecg waveform but still had spo2 and heart rate (hr) information.Tech support (ts) had the bme stop and restart monitoring room 511 and that did nothing.They rebooted the unit.After the first reboot, they could see waveforms in room 528.At that point, the bme stopped monitoring 511 and remonitored it, and they could then see spo2 and hr but no waveform.The cns was rebooted for the 2nd time, and they could see all the information this time.The 2nd reboot resolved all their issues.They have another cns in their telemetry room (6th floor) which is locally filing and could see all patient information in the tiles.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; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 17902212
• MDR Text Key: 326252869
• Report Number: 8030229-2023-03794
• 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: 01/03/2024

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: 09/09/2023
• Initial Date FDA Received: 10/09/2023
• Supplement Dates Manufacturer Received: 12/28/2023
• Supplement Dates FDA Received: 01/03/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/23/2018
• 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