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

Model Number CNS-6201A

Device Problems Device Alarm System (1012); Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138); No Display/Image (1183); Device Stops Intermittently (1599)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/05/2018

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer reported that the central nurse's station (cns) rebooted on its own.He stated that there were also reports of a blue screen and an alarm.The bme believes the alarm is from the ups and not the cns.Nihon kohden quality assurance is investigating the issue and has requested the crash dump files and the event logs.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.

Event Description

The biomedical engineer reported that the cns rebooted on its own.He stated that there were also reports of a blue screen and an alarm.

Event Description

The biomedical engineer reported that the cns rebooted on its own.He stated that there were also reports of a blue screen and an alarm.

Manufacturer Narrative

Details of the complaint on 04/05/2018, bme bob eggen at scl health system reported the cns-6201a (pu-621ra sn: (b)(4)) rebooted the day before on its own.There were reports of a blue screen and an alarm but bob thinks the alarm is from the ups and is irrelevant.The cns was connected to the remote pc solutions and is located in the network closet but the alarm was at the display side.Bob pulled the log files and saw errors around the time of the reported rebooting.Service requested troubleshooting/assistance.Service performed on 04/12/2018, bob reported nothing has happened since the reboot.Log files were requested from customer.Investigation result the cns warranty began 10/29/2017, which is approximately 5 months prior to reported issue.A review of device history found no other issues of rebooting reported.The unit was not returned and no nka evaluation could be performed.Condition of the unit is not known.Information on whether the cns was connected to a ups, along with age and condition of the ups, was not provided.Irc-nka300120949 was initiated on 04/12/18.Results of investigation found the monitoring tool had detected a system abnormality and performed a reboot to return to normal.Cause of the reboot could not be identified.Two conditions were identified which do not conform to installation guide, 2017 edition (0614-907705): setting of time synchro; multiple cns's were found to be set to "synchro with ntp server" and the org-9700 was not coped with enlarged network; maximum number which can be connected with the org-9700 was 340 however more than 340 were connected.Recommendation is to set only one cns on the network to perform "synchro with ntp server", and to change the org-9700 to org-9100 which can cope with a larger network.Based on the information provided, nkc was unable to identify a root cause.The device has no prior history of rebooting and no further issue was reported with the unit.Review of tickets opened at customer facility found no other tickets opened for cns rebooting.This issue is not suspected to be caused by deficient design or to have an adverse trend at customer site.

• Brand Name: CNS-6201A
• Type of Device: CENTRAL MONITOR SYSTEM
• Manufacturer (Section D): NIHON KOHDEN CORPORATION; 1-31-4 nishiochia, shinjuku-ku; attn: shama mooman; tokyo, 161-8 560; JA 161-8560
• MDR Report Key: 7488729
• MDR Text Key: 107595346
• Report Number: 8030229-2018-00143
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 04931921114131
• UDI-Public: 4931921114131
• Combination Product (y/n): N
• PMA/PMN Number: K102376
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 10/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2018
• 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
• Device Lot Number: NOT APPLICABLE
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/02/2019
• Distributor Facility Aware Date: 10/01/2019
• Device Age: 14 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/02/2019
• Date Manufacturer Received: 10/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NOT APPLICABLE
• Patient Sequence Number: 1