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

Model Number CNS-6201A

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Output Problem (3005); Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/26/2019

Event Type  malfunction  

Manufacturer Narrative

The nurse reported that the central nurse's station (cns) froze and was not responding earlier even though the vitals and numerics were still showing correctly, so they hard powered off the cns and now it will not boot up into windows.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 nurse reported that the central nurse's station (cns) froze and was not responding earlier even though the vitals and numerics were still showing correctly, so they hard powered off the cns and now it will not boot up into windows.No patient harm was reported.

Event Description

The nurse reported that the central nurse's station (cns) froze and was not responding earlier even though the vitals and numerics were still showing correctly, so they hard powered off the cns and now it will not boot up into windows.No patient harm was reported.

Manufacturer Narrative

Details of complaint: on (b)(6) 2019, customer reported cns, pu-621ra s/n (b)(6) was not responding.Vital signs and numerical values were showing correctly.After customer rebooted the cns, it failed to boot into windows.Device's boot sequence was stuck at "cns-6201.Please wait" screen.Customer was advised that device's raid feature was performing disk check after the hard reboot.Service requested: repair/loaner.Service performed: loaner.Investigation result: on 5/29/2019, customer returned the loaner.The cns serial number (b)(6) was never sent into nka for evaluation and/or repair.Cns-6201 service manual revision g states that regular inspection every six months should be conducted.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.In this case, device has a built-in raid setup that would allow user to replace one of the two mirrored hard drives, preventing both hard drive failures.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.No hard drive error messages were reported.Service history for this for this device shows the issue has not re-occurred.Device continues to be in service.Due to insufficient information available, the root cause of the reported message could not be determined.Investigation conclusion: due to insufficient information available, the root cause of the reported message could not be determined.Corrected information from initial mdr: d10 device not returned.F9 approximate age of device: incorrectly calculated.H3 device not returned.

• 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: 8642556
• MDR Text Key: 146352272
• Report Number: 8030229-2019-00172
• 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: 01/06/2020

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: 01/06/2020
• Distributor Facility Aware Date: 01/02/2020
• Device Age: 22 MO
• Event Location: Hospital
• Date Report to Manufacturer: 01/06/2020
• Initial Date Manufacturer Received: 04/26/2019
• Initial Date FDA Received: 05/24/2019
• Supplement Dates Manufacturer Received: 01/02/2020
• Supplement Dates FDA Received: 01/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NOT APPLICABLE
• Patient Sequence Number: 1