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

Model Number CNS-6801A

Device Problems Device Alarm System (1012); No Audible Alarm (1019); Alarm Not Visible (1022)

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

Event Date 12/01/2023

Event Type  malfunction  

Event Description

The biomedical engineer (bme) reported that the central nurses station (cns) did not alarm for vtach or vfib.No patient harm was reported.

Manufacturer Narrative

The biomedical engineer (bme) reported that the central nurses station (cns) did not alarm for vtach or vfib.They will send the log files in for evaluation by nk.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 contain no information (ni), as attempts to obtain the information were made, but none were provided.A2 - a6.B6 - b7.D10.Attempt #1 12/04/2023 emailed the bme for all items under the no information list.No reply was received.Attempt #2 12/12/2023 emailed the bme for all items under the no information list.No reply was received.Attempt #3 12/19/2023 emailed the bme for all items under the no information list.The bme emailed the patient demographics were unknown, and the cns was only monitoring gz-130s transmitters but did not know which ones.Additional device information: d10 concomitant medical device: the following devices were used in conjunction with the cns: gz-130 transmitters model #: ni.Serial #: ni.Device manufacturer data: ni.Unique identifier (udi) #: ni.Returned to nihon kohden.

Manufacturer Narrative

Details of complaint: the biomedical engineer (bme) reported that the central nurses station (cns) did not alarm for vtach or vfib.The customer sent in photos to send to our clinical application specialist (cas) for review.They confirmed the cns should have alarmed and recommended in order to investigate the issue further, logs should be pulled.There was patient involvement when the issue occurred, but no report of injury, no harm, nor any adverse event, due to the reported issue.Investigation summary: we were able to confirm the cns should have alarmed vtach or vfib.However, a definitive root cause could not be determined.The customer did not provide device logs after multiple good faith effort (gfe) attempts.Logs relating to the event can no longer be obtained due to too much time having passed.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.It is likely that the customer changed the alarm settings after the event to resolve the issue.We found several causes of vtach-related issues not alarming.These include incorrect settings/user error on the input device (e.G., bsm-, gz, or zm devices), inadequate patient preparation or calibration, faulty leads, and environmental interference.The "suspend alarms" setting should not interfere with live monitoring.The user must be extremely careful when setting the alarm to "off," as this would turn off all alarms that would alert staff of a medical event.Nk will continue to monitor and trend similar complaints.A serial number review of the reported device does not reveal additional related complaints.Complaint history review of the customer's account does not reveal trends for similar complaints.Nk will continue to monitor and trend similar complaints.Attempt #3 12/19/2023 emailed the bme for all items under the no information list.The bme emailed the patient demographics were unknown, and the cns was only monitoring gz-130s transmitters but did not know which ones.

Event Description

The biomedical engineer (bme) reported that the central nurses station (cns) did not alarm for vtach or vfib.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: 18398355
• MDR Text Key: 331390464
• Report Number: 8030229-2023-04007
• 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: 03/08/2024

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: 12/01/2023
• Initial Date FDA Received: 12/27/2023
• Supplement Dates Manufacturer Received: 03/06/2024
• Supplement Dates FDA Received: 03/08/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/11/2021
• 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-130S; GZ-130S