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); Device Inoperable (1663); Unexpected Shutdown (4019)

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

Event Date 05/10/2018

Event Type  malfunction  

Manufacturer Narrative

The customer reported that the cns shutdown during patient use and would not boot back up into windows.The system stops on the intel matrix storage manager.He swapped the two hard drives but the issue persists.The customer ordered new hard drives and nk technical support will assist with configuring the hard drives.No 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 customer reported that the central nurses' station (cns) shutdown during patient use and would not boot back up into windows.The system stops on the intel matrix storage manager.

Manufacturer Narrative

Details of the complaint on (b)(6) 2018, (b)(6) reported the cns-6201a (pu-621ra sn:(b)(6)) would not boot into windows.The systems stop on the intel matrix storage manager.Issue not resolved upon swapping hard drive 0 and 1.Service requested troubleshooting/assistance service performed 2 hard drives sent to customer, one configured and one blank investigation result the cns warranty began 01/29/14, which is over 4 years prior to the reported issue.A review of device history found related issue reported one month prior: (b)(4) reported (b)(6) 2018 in which cns would not boot up after a generator test.Customer was advised to work with their it to restore raid 1 volume.Due to lack of customer response, it is unknown if hard drives were replaced.The hdd is susceptible to degradation from age, use, power, and other conditions at the facility.Performance of generator tests without use of a ups is likely to contribute to hdd damage.Information on whether the cns was connected to a ups, along with age and condition of the ups, is not provided.The cns-6201a uses a dual hard drive system with a raid controller.This system provides redundancy on the hard drive to prevent data loss or system failure caused by a failed hard drive.It is important that the failed drive be replaced to prevent a complete system failure that would occur if both drives fail.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, internal sensor and hard drive condition should be checked through procedures outlined on section 5.11 of the service manual.This inspection would show the critical hardware information which would prompt user to perform needed maintenance.Additionally, device will give an error message when hard disk drive error is detected, prompting user to replace hard disk drive: "hdd [port x] error" where x is either 0 or 1.Troubleshooting of the hdd and error message, along with the proper actions to take is addressed in the service manual.The service manual also provides steps on how to replace the hdd.Cns-6201a service manual advises that one hdd can be replaced without stopping of monitoring.For software versions 02-40 or earlier, there was a concern that the clinical user was able to close the error messages without replacing the failed drive.Per (b)(4) issued (b)(6) 2016, a patch was created for software versions 02-40 or below which would have error message altered to not interfere with patient monitoring data, and to not be removed from the screen unless by a specific sequence of clicks.With this fail-safe system, both hard drives failure is prevented when user follows prescribed maintenance procedures.Customer's maintenance information on this device is not available.Per nkc dhr, the unit (pu-621ra sn: (b)(6)) 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 in the manufacturing of the device.Based on the required maintenance procedures, a scenario where both hard drives fail is when the first hard drive failure is not addressed by the user.Thus, it is likely that lack of device maintenance lead to both hard drive failures.

Event Description

The customer reported that the central nurses' station (cns) shutdown during patient use and would not boot back up into windows.The system stops on the intel matrix storage manager.

• 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: 7584573
• MDR Text Key: 110577167
• Report Number: 8030229-2018-00197
• 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: 08/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2018
• 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: 08/29/2019
• Distributor Facility Aware Date: 08/28/2019
• Device Age: 57 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/29/2019
• Date Manufacturer Received: 08/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NOT APPLICABLE
• Patient Sequence Number: 1