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

Model Number CNS-6201A

Device Problems Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138); Electrical /Electronic Property Problem (1198); Device Stops Intermittently (1599); Device Inoperable (1663); Device Issue (2379); Device Operates Differently Than Expected (2913); Unexpected Shutdown (4019)

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

Event Date 04/12/2018

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer reported that the central nurse's station (cns) rebooted randomly while in patient use.They requested that nihon kohden (nk) check the event logs.Nihon kohden technical support specialist sent the customer a request for the event logs to be submitted to nk through dropbox.Nihon kohden continues to investigate the reported event.Nihon kohden will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.No patient harm was reported.

Event Description

The biomedical engineer reported that the central nurse's station (cns) rebooted randomly while in patient use.

Event Description

The biomedical engineer reported that the central nurse's station (cns) rebooted randomly while in patient use.

Manufacturer Narrative

Details of the complaint on (b)(6) 2018, customer at (b)(6) reported the cns-6201a (pu-621ra sn:(b)(6)) reboots randomly.Service requested customer requested to have the event logs checked.Service performed files needed for log investigation are not available.Customer no longer wished to have log investigation performed and reported no further problems with the unit.Investigation results 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.The device warranty began 03/30/17.The issue was reported after approximately 1 year at customer facility.Review of device sap history found no previously reported issues with the unit rebooting.Review of tickets opened at user facility found no other issues opened for issues with "reboot".Review of tickets opened at other facilities using similar tickets query found reported issues of: "pu-621ra reboot" (1) (b)(4) reported (b)(6) self rebooted.Suspected cause: improper maintenance (2) (b)(4) reported (b)(6) spontaneously rebooted.Bme was unsure when the last time the device was restarted.The unit was returned and nka evaluation was unable to duplicate the reported issue.(3) (b)(4) reported (b)(6) was reported to restart on its own during normal operation.Investigation found the file system structure on the disk was corrupt and unusable.This could cause a reboot.Customer was advised to run check disk and check for damage/replace if necessary.(4) (b)(4) reported (b)(6) was reported to spontaneously reboot.Last preventive maintenance (pm) performed was two years prior.(5) (b)(4) reported (b)(6) was reported to randomly reboot.Customer stated the issue occurred a couple months prior and was isolated to faulty ups system.The above reported issues show a trend of improper cns care/maintenance which is likely to influence rebooting of the cns.The cns-6201a service manual revision g recommends that regular maintenance inspections be performed every 6 months.A maintenance check sheet is provided, which includes checking the operation of the unit and status of hardware information.In particular, fan operation should be checked through procedures outlined on section 5.3 of the service manual, and internal sensor, fan, and hard drive condition should be checked through procedures outlined on section 5.12 of the service manual.This inspection would show the critical hardware information which would prompt user to perform needed maintenance.Cns-6201a operator's manual also advises the customer to restart the central monitor once every three months.Otherwise, operation becomes unstable and monitoring may stop.While restarting, patients monitored by the central monitor must be monitored by alternate instruments such as bedside monitors.As the device was not returned, nka evaluation could not be performed.Additionally, investigation is limited as further information regarding the incident, including cns logs for the event, is not available.Additionally, customer's maintenance history on this device is not available.Unit has no prior history of rebooting.The root cause could not be determined as information is limited.However, customer reported no further problems with the unit.No hardware deficiency is suspected as issue appeared to clear without nka servicing or assistance.No adverse trend for this issue has been found 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: 7503738
• MDR Text Key: 107962748
• Report Number: 8030229-2018-00148
• 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: 10/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2018
• 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: 10/24/2019
• Distributor Facility Aware Date: 10/23/2019
• Device Age: 26 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/24/2019
• Date Manufacturer Received: 10/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NOT APPLICABLE
• Patient Sequence Number: 1