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

Model Number CNS-6201A

Device Problems Device Stops Intermittently (1599); Device Operational Issue (2914); Unexpected Shutdown (4019)

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

Event Date 05/02/2018

Event Type  malfunction  

Manufacturer Narrative

The customer reported that the central nurse's station (cns), which is a consignment unit use while another unit is in for repair, powered down on its own then restarted.The device is still in use at the hospital and is working properly.It will not be sent in to nihon kohden for evaluation.No harm was reported.The dump files and event log files were sent to nihon kohden for evaluation.Nihon kohden determined that the reboot could not be confirmed based on what was reviewed in the log files.It was recommended that the hospital update their software to the latest version, which has enhanced log functions.

Event Description

The customer reported that the central nurse's station (cns), which is a consignment unit they are using while another unit is repaired, powered down on its own then restarted.

Event Description

The customer reported that the central nurse's station (cns), which is a consignment unit they are using while another unit is repaired, powered down on its own then restarted.

Manufacturer Narrative

Additional narrative: on (b)(6) 2018 (b)(6) at kaiser permanente reported the cns-6201a (pu-621ra sn: (b)(6)) rebooted itself.The unit was put into service the previous week, then rebooted itself shortly after.The exact date was unclear.This made the nurses nervous as it appeared to be the same thing.This issue is different from the other unit (sn: (b)(6) ticket 22776) which had a blue screen and was brought in for repair.Field support engineer ensured the unit was operating properly.Service requested troubleshooting/assistance.Service performed log files were collected.Investigation result the unit was a consignment unit that was not put in place at the site until (b)(6) 2018.The unit was previously in use at other facilities: (b)(6) 2016 - unit sent to university hospital and clinics.Customer reported no issues with the unit (b)(6) 2016 - unit sent to chi st.Luke's health memorial.Customer reported (b)(6) 2017 in notification 300099779 unit could not pull up full disclosure.The cns was set up in a training environment.There was a suspected hard drive issue.Unit was exchanged and repaired at nka.(b)(6) 2017 - unit sent to houston marriott medical center.Customer requested to return unit on 12/21/17 notification 300107639 due to unit no longer needed.Nka evaluated unit and found no issues (b)(6) 2018 - unit sent to kaiser permanente san diego central customer reported the cns rebooted shortly after installation.Investigation of log files determined the following: (1) system startup occurred on (b)(6) 2018.(2) there was no log of reboot after (b)(6) 2018 (3) there no log of unusual starting of the application based on the available information, reboot and ungraceful exit of the application could not be confirmed.The software version of the device was ver.02-53 and was not the latest version.The newest version has enhanced log functionality and countermeasures for some reboots.Software version was recommended to be upgraded.Review of device sap history shows recurrence of the rebooting issue for this unit.Notifications/tickets opened for this issue are listed below: 300130531/32940 reported 07/02/18.300131182/33547 reported 07/10/18.300137924/38413 reported 09/04/18.300162591/53483 reported 03/08/19.Per nkc dhr, the unit has had no history of ncmr, deviation, or capa during manufacturing of the device.The device has not been refurbished and there were no discrepancies or unusual findings before device release that might relate to the reported issue.This issue is not suspected to be caused by a deficiency during manufacturing of the device.Review of tickets opened at the facility found additional reported issues for other pu-621ra units rebooting: 300114526/22167 reported 02/20/18 for sn: ? 300148360/42339 reported 10/22/18 for sn: (b)(4).The above reported issues show a trend of improper cns maintenance.This does not appear to be related to the current issue.The current issue seems to be isolated to the facility (kaiser permanente san diego).Further troubleshooting of this issue has been documented in notification 300137924.At this time, issue is not suspected to be related to the cns, but tied to the environment/physical location of the cns as it has been found to continue occurring with replacement cns's.Issue also not believed to be a power issue as the ups was replaced.Refer to notification 300137924/ticket 38413 for updated troubleshooting information and investigation results.Investigation results status for the notification is pending due to troubleshooting in progress.Corrected information: date received by manufacturer: should be 05/02/2018 not 05/31/2018 as listed on mdr initial report.

• 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: 7558754
• MDR Text Key: 109745804
• Report Number: 8030229-2018-00189
• 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: 08/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2018
• 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: 08/01/2019
• Distributor Facility Aware Date: 08/01/2019
• Device Age: 31 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/01/2019
• Date Manufacturer Received: 08/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NOT APPLICABLE
• Patient Sequence Number: 1