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

Model Number CNS-6801A

Device Problems No Audible Alarm (1019); Alarm Not Visible (1022); Protective Measures Problem (3015)

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

Event Date 10/17/2023

Event Type  malfunction  

Event Description

The biomedical engineer (bme) reported that the central nurses station (cns) did not give an audible or visual alarm for an a-fib event.No patient harm was reported.

Manufacturer Narrative

The biomedical engineer (bme) reported that the central nurses station (cns) did not give an audible or visual alarm for an a-fib event.Bme was going through the adverse event log and capturing all required data.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.Attempt #1 10/18/2023 emailed the bme for all items under the patient information and concomitant devices.They responded with the concomitant devices.Attempt #2 10/24/2023 emailed the bme for the patient information.No reply was received.Attempt #3 11/03/2023 emailed the bme for the patient information.The bme replied that the information was unknown.Additional device information: d10 concomitant medical device: the following devices were used in conjunction with the cns: bsm-6000: model #: mu-651ra.Serial #: (b)(6).Device manufacturer data: 29/06/2020.Unique identifier (udi) #: (b)(4).Returned to nihon kohden: na.Bsm-1700: model #: bsm-1753a.Serial #: (b)(6).Device manufacturer data: 03/04/2017 unique identifier (udi) #: (b)(4) returned to nihon kohden: na.

Manufacturer Narrative

Details of complaint: the biomedical engineer (bme) reported that the central nurse's station (cns) did not give an audible or visual alarm for an a-fib event.No patient harm was reported.Investigation summary: nihon kohden (nk) was unable to confirm the reported issue.The quality team followed up with nk clinical specialist to review the event.They discovered interference on the ecg tracing.Clinical also advised that if the silence alarm button was pressed, as the customer is stating, this would silence all alarms.Unless there was a breach in another vital sign or arrhythmia alarm, the alarm would start alarming.But based on the available information, the most probable root cause was potentially due to the alarm being silenced which would silence all alarms.There is no proof the device malfunctioned as there was evidence the silence button was pressed.However, a definitive root cause could not be determined.As no further response was made by the customer relating to the device not alarming, it is likely that the customer was able to resolve the issue without additional support.Not alarming and incorrect alarm settings are an inconvenience to the user as it would not alert that a medical event may have occurred even when the patient is unstable.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 (e.G., bsm-, gz, or zm devices), 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).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.A serial number review of the reported device (model: pu-681ra, 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.Additional device information: d10 concomitant medical device: the following devices were used in conjunction with the cns: bsm-6000: model #: mu-651ra serial (b)(6) device manufacturer data: 29/06/2020 unique identifier (b)(4) returned to nihon kohden: na.Bsm-1700: model #: bsm-1753a serial (b)(6) device manufacturer data: 03/04/2017 unique identifier (b)(4) returned to nihon kohden: na.

Event Description

The biomedical engineer (bme) reported that the central nurse's station (cns) did not give an audible or visual alarm for an a-fib event.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: 18127563
• MDR Text Key: 328280445
• Report Number: 8030229-2023-03857
• 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: 03/29/2024

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: 10/17/2023
• Initial Date FDA Received: 11/13/2023
• Supplement Dates Manufacturer Received: 03/28/2024
• Supplement Dates FDA Received: 03/29/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/09/2018
• 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
• Treatment: BSM-1700; BSM-1700; BSM-6000; BSM-6000
• Patient Ethnicity: Hispanic