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

Model Number CNS-6801A

Device Problems No Audible Alarm (1019); Protective Measures Problem (3015); Data Problem (3196)

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

Event Date 06/06/2023

Event Type  malfunction  

Event Description

The customer reported that this central nurse's station (cns) is not alarming for tachy/brady for some patients on transmitters.There was no patient injury reported.

Manufacturer Narrative

The customer reported that this central nurse's station (cns) is not alarming for tachy/brady for some patients on transmitters.The customer is also unable to pull up arrhythmia recall for these patients at all.The unit is being exchanged as it is only a few months old.There was no patient injury 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 information were made, but not provided: a2 - a6 attempt # 1: (b)(6) 2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: (b)(6)2023 a phone call was made in an attempt to gather patient and device information; a voice mail was left for (b)(6) to call me back with this information.Attempt # 3 (b)(6) 2023 a phone call was made in an attempt to gather patient and device information; a voice mail was left for (b)(6) to call me back with this information.B6 attempt # 1: (b)(6) 2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: (b)(6) 2023 a phone call was made in an attempt to gather patient and device information; a voice mail was left for (b)(6) to call me back with this information.Attempt # 3 (b)(6) 2023 a phone call was made in an attempt to gather patient and device information; a voice mail was left for (b)(6) to call me back with this information.B7 attempt # 1: (b)(6) 2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: (b)(6) 2023 a phone call was made in an attempt to gather patient and device information; a voice mail was left for (b)(6) to call me back with this information.Attempt # 3 (b)(6) 2023 a phone call was made in an attempt to gather patient and device information; a voice mail was left for (b)(6) to call me back with this information.Additional model information: d10 concomitant medical device: the following device was used in conjunction with the cns: transmitters: model #: ni.Serial #: ni.Device manufacturer data: ni.Unique identifier (udi) #: ni.Returned to nihon kohden: ni.Additional model information: d10 concomitant medical device: the following device was used in conjunction with the cns: org: model #: ni.Serial #: ni.Device manufacturer data: ni.Unique identifier (udi) #: ni.Returned to nihon kohden: ni.

Event Description

The customer reported that the central nurse's station (cns) was not alarming for tachy/brady for some patients on transmitters.This was discovered during the initial device setup.They were also unable to pull up any arrhythmia recall data for these patients.No patient harm was reported.

Manufacturer Narrative

Details of complaint: the customer reported that the central nurse's station (cns) was not alarming for tachy/brady for some patients on transmitters.This was discovered during the initial device setup.They were also unable to pull up any arrhythmia recall data for these patients.No patient harm was reported.Investigation summary: as the reported device was not available for evaluation, the reported issue could not be duplicated nor confirmed.As such, a root cause cannot be determined.While troubleshooting the reported cns, nka technical support (ts) believed the issue was with the cns itself.The cns was replaced to resolve the issue.No further issues were reported with the replacement cns (pu-681ra sn: (b)(6)) relating to missed alarms or arrhythmia recall issues.Possible causes may be related to hardware failure or software corruption.All settings were verified to be correct.The reported device was newly installed the previous month and is determined to be an out-of-box failure.Out-of-box failures are often reported during the installation of a nihon kohden device and are often reported by a nihon kohden installer.Should a product malfunction during device set-up or installation, the complaint will be categorized as an out-of-box failure.An out-of-box failure is a product malfunction that occurs before patient use.Corruption of software or protocols on the system can lead to failures in operation.The most common causes for software corruption are ungraceful exits due to use error or power loss.Improper system shutoff is likely to corrupt files and software while performing operations.Or manufacturing of the device.Hardware failure could come as a result of physical damage, fluid damage, heat damage, or electrical damage.Physical damage could occur due to impacts with objects and other surfaces.Fluid intrusion would result in electrical damage to internal components as well as possible corrosion.Heat damage could occur due to improper maintenance or device placement.Electrical damage could occur during a power outage or power surge.Follow up attempts to the customer to obtain additional information were not answered.

• 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: 17262928
• MDR Text Key: 318471301
• Report Number: 8030229-2023-03620
• Device Sequence Number: 1
• Product Code: MHX
• 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: 02/14/2024

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: 06/06/2023
• Initial Date FDA Received: 07/05/2023
• Supplement Dates Manufacturer Received: 01/16/2024
• Supplement Dates FDA Received: 02/14/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/08/2022
• 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 TRANSMITTERS; ORG; ORG; TRANSMITTERS