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

Model Number CNS-6801A

Device Problems Device Alarm System (1012); Protective Measures Problem (3015)

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

Event Date 01/30/2024

Event Type  malfunction  

Manufacturer Narrative

Nk employee technical service account manager (tsam) emailed reporting the central nurses station (cns) did not alarm vtach when a patient experienced multiple episodes.Tsam collected the logs from the cns for review.There were no reports of patient harm or injury.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.Attempt # 1: 02/01/2024 emailed the nk employee tsam and the biomedical engineer (point of contact), for the concomitant medical device and patient information.No reply was received.Attempt # 2: 02/08/2024 emailed the nk employee tsam, biomedical engineer, and the customer for the concomitant medical device and patient information: the customer replied with most of he patient's information but did not have the concomitant medical device./.

Event Description

The nk employee tsam emailed reporting the central nurses station (cns) did not alarm vtach when a patient experienced multiple episodes.No patient harm was reported.

Event Description

The nk employee tsam emailed reporting the central nurses station (cns) did not alarm vtach when a patient experienced multiple episodes.No patient harm was reported.

Manufacturer Narrative

Details of complaint: nk employee technical service account manager (tsam) emailed reporting the central nurses station (cns) did not alarm vtach when a patient experienced multiple episodes.Tsam collected the logs from the cns for review.There were no reports of patient harm or injury.Investigation summary: although the cns log was obtained, the cause as to why the vtach alarm not occurring could not be investigated by only the log analysis without the time this event occurred.The investigation could not be conducted since the necessary information for the investigation could not be obtained after multiple attempts.As such we were unable to determine a definitive root cause.Alarms are triggered by limits configured in the alarm settings.Devices are configured as per customer requirements by the nk clinical staff at the time the devices are taken live.Additional changes to device settings can be made post-go-live by the customer based on their facility needs, policy, protocols, and workflow.No alarms may occur due to incorrect settings/user error (upper or lower limit of the alarms are set incorrectly or not calibrated), incorrect settings on the input device, inadequate patient preparation (improper lead placement and incorrect lead selection), faulty leads (poor reception or weak signals from the patient which may lead to a false alarm), the "suspend alarms" setting set to "on" (this will mark all alarms as suspended but will not interfere with live monitoring), and environmental interference (electronic devices may interfere with the reception of the signal or may induce a signal which could cause a false alarm).A review of historical data does not reveal any significant trends that would contribute to component failure, related to the device's design or manufacturing.This was the only complaint identified regarding the device, (pu-681ra, serial number: (b)(6) for the vtach alarm over the two years.A review of historical data does not reveal a significant trend that would contribute to component failure that is related to the design or manufacturing of the device.We will continue to monitor trends for this device and facility for similar complaint issues.Concomitant medical device and patient information: the customer replied with most of the patient's information but did not have the concomitant medical device.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 nk employee (b)(6) emailed reporting the central nurses station (cns) did not alarm vtach when a patient experienced multiple episodes.No patient harm was reported.

Manufacturer Narrative

Details of complaint: nk employee technical service account manager (b)(6) emailed reporting the central nurses station (cns) did not alarm vtach when a patient experienced multiple episodes.Tsam collected the logs from the cns for review.There were no reports of patient harm or injury.Investigation summary: although the cns log was obtained, the cause as to why the vtach alarm not occurring could not be investigated by only the log analysis without the time this event occurred.The investigation could not be conducted since the necessary information for the investigation could not be obtained after multiple attempts.As such we were unable to determine a definitive root cause.Alarms are triggered by limits configured in the alarm settings.Devices are configured as per customer requirements by the nk clinical staff at the time the devices are taken live.Additional changes to device settings can be made post-go-live by the customer based on their facility needs, policy, protocols, and workflow.No alarms may occur due to incorrect settings/user error (upper or lower limit of the alarms are set incorrectly or not calibrated), incorrect settings on the input device, inadequate patient preparation (improper lead placement and incorrect lead selection), faulty leads (poor reception or weak signals from the patient which may lead to a false alarm), the "suspend alarms" setting set to "on" (this will mark all alarms as suspended but will not interfere with live monitoring), and environmental interference (electronic devices may interfere with the reception of the signal or may induce a signal which could cause a false alarm).A review of historical data does not reveal any significant trends that would contribute to component failure, related to the device's design or manufacturing.This was the only complaint identified regarding the device, (pu-681ra, serial number: (b)(6) for the vtach alarm over the two years.A review of historical data does not reveal a significant trend that would contribute to component failure that is related to the design or manufacturing of the device.We will continue to monitor trends for this device and facility for similar complaint issues.Updated investigation summary: nk tsam submitted additional cns data logs and a video to nkc for review on 04/11/2024, and nkc continued the investigation into the same issue that occurred on 01/30/2024.Nkc found that gz-130pa (serial number: unknown, software version 02-42) was used, even though the initial report was related to the cns.Nkc analyzed a movie of real-time electrocardiograms and pulse waves taken on the cns screen for all patients.They found that pulse waves had disappeared, and v tachy had occurred.However, the shapes of normal beats and vpc beats are similar, so it was not judged as vpc this time due to the performance limit of the pattern matching method using shape templates.Nkc recommends that the customer try changing the electrode position, as the shape of normal beats and vpc beats may be recognized differently, which may result in a vpc determination.If it is not possible to determine a vpc, please be aware of the upper heart rate alarm setting.Also, depending on the sv tachy settings, it may be determined to be sv tachy.The reported issue could not be confirmed or conclusively identified due to insufficient information, and it appears to be user-dependent.Despite multiple follow-up attempts, the customer did not respond to our inquiries or nkcs' requests for further details.However, based on the available information, the most likely causes may include user errors related to alarm settings, potential misplacement of electrodes, patient conditions, or environmental/electromagnetic disturbances.During review of device history, this was found to be an isolated issue.There is no indication of improper/inadequate device design, as there has been no significant trend for this issue, as only 1 (one) reported issues with this device has been reported, at the facility, occurred in the past 3 (three) years.Nk will continue to monitor trends for this device and facility for similar complaint issues.Attempt: (b)(6) 2024 emailed the nk employee (b)(6) and the biomedical engineer (point of contact), for the concomitant medical device and patient information.No reply was received.Attempt: (b)(6) 2024 emailed the nk employee (b)(6), biomedical engineer, and the customer for the concomitant medical device and patient information: the customer replied with most of the patient's information but did not have the concomitant medical device.Gz transmitter.Model #: gz-130pa.Serial #: ni.Device manufacturer data: ni.Unique identifier (udi) #: (b)(4).Returned to nihon kohden: na.Additional information: b4 date of this report d10 concomitant medical device g3 date received by manufacturer g6 type of report h6 event problem and evaluation codes h11 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: 18753458
• MDR Text Key: 336966453
• Report Number: 8030229-2024-04148
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/02/2024

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: 01/30/2024
• Initial Date FDA Received: 02/21/2024
• Supplement Dates Manufacturer Received: 04/02/2024
• Supplement Dates FDA Received: 04/02/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/10/2021
• 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
• Treatment: GZ-130PA.; NI.; NI.
• Patient Age: 93 YR
• Patient Sex: Male
• Patient Weight: 67 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White