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

Model Number CNS-6201A

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/14/2019

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer reported that the central nurse's station (cns) restarted on its own.Device came back up with no issue.We have requested several times for logs and information on what devices were being monitored but the customer has not responded back with this information.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 if additional information becomes available.

Event Description

The biomedical engineer reported that the central nurse's station (cns) restarted on its own.Device came back up with no issue.We have requested several times for logs and information on what devices were being monitored but the customer has not responded back with this information.No patient harm was reported.

Manufacturer Narrative

Details of the complaint on (b)(6) 2019, travis fritz at essentia health fargo innovis health reported the cns-6201a (pu-621ra sn:(b)(6) restarted on its own.The device came back up with no issues.Service requested customer would like to know what happened and how they can prevent it.Service performed customer was advised the device should be restarted every 90 days.The device had not been restarted lately.Customer was advised to check the raid status, and both drives were confirmed to be good.Biomed was provided instructions if he wanted to send in the log files.Multiple attempts were made to follow up with the customer, receiving no response.Investigation result the cns warranty began (b)(6) 2015, which is almost 4 years prior to reported issue.A review of device history found one previously reported issue with the cns: notification 300078149 reported (b)(6) 2018: there was an issue with changing time on the cns.This does not appear to be related to the current reported issue.Per cns-6201a service manual, a restart once every three months should be performed in order to maintain stable operation.It was found that the cns had not been restarted lately.Lack of proper preventive maintenance has potential to contribute to the reported issue.Troubleshooting of the cns is outlined in the service manual.Upon detection of slow operation or malfunction, the recommended action to take is to restart the cns.Irc-nka300170339 was opened on (b)(6) 2019 to investigate a similarly reported issue at wyoming medical center in which cns (pu-621ra sn: (b)(6).Was reported to restart on its own.Investigation determined there was an error log that the file system structure was corrupt which was the cause for the reboot.Customer was advised to run the chkdsk utility on volume c:.Due to lack of log files provided by the customer, investigation into the event is limited.Customer was unresponsive to requests for follow up and the root cause could not be determined.Unit's status and drives were confirmed to be good.No further reported issues with the cns.Review of tickets opened at the customer facility found no other issues of cns restarting.Customer has no adverse trend of the cns restart.Corrected information: f9.Approximate age of device: incorrectly calcuated g4.Date received by manufacturer: should be (b)(6) 2019 not (b)(6) 2019 as listed on mdr initial report.

Event Description

The biomedical engineer reported that the central nurse's station (cns) restarted on its own.Device came back up with no issue.We have requested several times for logs and information on what devices were being monitored but the customer has not responded back with this information.No patient harm was reported.

• 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: 8509298
• MDR Text Key: 141770949
• Report Number: 8030229-2019-00088
• 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

• 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: 52 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/02/2019
• Initial Date Manufacturer Received: 04/12/2019
• Initial Date FDA Received: 04/12/2019
• Supplement Dates Manufacturer Received: 10/01/2019
• Supplement Dates FDA Received: 10/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NOT APPLICABLE
• Patient Sequence Number: 1