MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION CNS-6201A; CENTRAL MONITOR SYSTEM

Model Number CNS-6201A

Device Problems Loss of Data (2903); Data Problem (3196)

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

Event Date 10/04/2023

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer (bme) reported that the central nurse's station (cns) is having issues with waveforms freezing and disappearing, but the heart rate remains still, this happens about every 8 hours.The bme checked the logs and noticed an error message saying, "mcafee solidifier prevent unauthorized execution of windows".No patient harm was reported.Technical support recommended that the bme send this unit into nk repair center.Service performed: device was received into nihon kohden repair center and inspection found there was no physical damage or fluid intrusions.The reported problem of waveforms freezing and disappearing, was duplicated.The system board is corrupted.There were beeping noises when turning on the unit.The motherboard pcb is no longer being supported by nkc.It is recommended that the customer do an exchange for this unit.This unit has been in use since 2017 and review of the service history for this sn cns shows that it has never been sent into nka for a hard drive replacement.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.

Event Description

The biomedical engineer (bme) reported that the central nurse's station (cns) is having issues with waveforms freezing and disappearing, but the heart rate remains still, this happens about every 8 hours.The bme checked the logs and noticed an error message saying, "mcafee solidifier prevent unauthorized execution of windows".No patient harm was reported.Technical support recommended that the bme send this unit into nk repair center.

Event Description

The biomedical engineer (bme) reported that the central nurse's station (cns) is having issues with waveforms freezing and disappearing, but the heart rate remains still, this happens about every 8 hours.The bme checked the logs and noticed an error message saying, "mcafee solidifier prevent unauthorized execution of windows".No patient harm was reported.Technical support recommended that the bme send this unit into nk repair center.

Manufacturer Narrative

Reported complaint: the biomedical engineer (bme) reported that the central nurse's station (cns) is having issues with waveforms freezing and disappearing, but the heart rate remains still, this happens about every 8 hours.The bme checked the logs and noticed an error message saying, "mcafee solidifier prevent unauthorized execution of windows".No patient harm was reported.Technical support recommended that the bme send this unit into nk repair center.Service performed: device was received into nihon kohden repair center and inspection found there was no physical damage or fluid intrusions.The reported problem of waveforms freezing and disappearing, was duplicated.The system board is corrupted.There were beeping noises when turning on the unit.The motherboard pcb is no longer being supported by nkc.It is recommended that the customer do an exchange for this unit.This unit has been in use since 2017 and review of the service history for this sn cns shows that it has never been sent into nka for a hard drive replacement.Investigation summary: the reported issue of the waveforms freezing and disappearing was confirmed and verified.A definitive root cause could not be determined.Upon evaluation from repair center, they discovered the unit required an hdd replacement and a new pcb main board caused by normal wear and tear (degradation of internal parts) (device was purchased in may of 2017).This could be the contributing cause of the waveforms freezing, disappearing and the error message they were experiencing.Repair center recommended an exchange for the defective device.The customer denied the exchange and requested their unit back unrepaired, as they will be upgrading 3 cnss soon.An hdd port error message prompts the user to check the condition of the hdds when it has exceeded 20,000 hrs.Of runtime.Users may replace the hdds or may continue to use the hdd after the inspection of the condition of the hdd.Failure to replace the hdd or inspect the hdd may lead to hdd failure.Fuzzy or inaccurate waveforms (e.G., sawtooth patterns) and wave artifacts (signal noise, lead placement, lead connection, network interference) are caused by faulty lead placement/faulty leads.Lead sets are used to acquire ecg readings, and the users should verify that the leads are authorized for use with the bsm in operation before monitoring a patient.Improper connection of leads (leads not properly seated), and/or damaged or contaminated leads (dirt, dust and/or cleaning residues) may contribute to ecg issues.If the leads are not seated properly to the bsm, readings will not appear properly.Users should ensure that all cable connections are secure before monitoring a patient.Damage to lead sets are most likely a result of mishandling that results in the damage to the inner wires of the leads.Damage to the conductive wires would prevent data from reaching the bsm and transferring over to the cns.Buildup of residues on contact points could interfere with the stable flow of data or create a weak signal that may appear as a flat line on the cns or as broken waveforms.Lead issues resulting in the above-mentioned failure modes would be immediately recognizable by the user and addressed promptly.These factors can also lead to missing numerics or numerics but no waveforms on a tile or missing expanded waveforms or waveforms that appear cut off.Device history: a serial number review of the reported device (pu-621ra, serial number (b)(6)) does not reveal additional related complaints.Complaint history review of the customer's account does not reveal trends for similar complaints.The following fields contains no information (ni), as attempts to obtain information were made, but the information was not provided.Attempt #1: on 10/23/2023, emailed customer via microsoft outlook for all items under the no information section.Automatic reply was received stating the biomed is out of the office and cannot provide any further information.

• Brand Name: CNS-6201A
• 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: 18014363
• MDR Text Key: 327299651
• Report Number: 8030229-2023-03834
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 04931921114131
• UDI-Public: 04931921114131
• 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: Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 01/16/2024

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-6201A
• Device Catalogue Number: PU-621RA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/04/2023
• Initial Date FDA Received: 10/26/2023
• Supplement Dates Manufacturer Received: 01/12/2024
• Supplement Dates FDA Received: 01/16/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/22/2016
• 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