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

Model Number CNS-6201A

Device Problems Failure to Power Up (1476); Power Problem (3010)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/20/2019

Event Type  malfunction  

Manufacturer Narrative

The customer reported that the central nurse's station (cns) is not booting up after a power outage.The customer also reported that after the unit powers on, it does not launch the cns software, but goes into the windows screen instead.Nk ts advised the customer to swap the cns hard drives.The customer later reported that this resolved the issue.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 nurse's station (cns) is not booting up after a power outage.

Event Description

The customer reported that the central nurse's station (cns) is not booting up after a power outage.

Manufacturer Narrative

Complaint information: on 11/20/2019, customer at ste.Genevieve co memorial hospital reported cns program will not start up on pu-621ra with serial# (b)(6).Investigation summary: root cause of the issue was identified to be hard disc drive performing disk check at the time of launching the cns software.Warranty of the device is valid till 09/26/2017.According to the table in quality complaint investigations work instruction, with document id: sop07-018, the risk priority of the issue is categorized as: medium.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.

• 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: 9470245
• MDR Text Key: 200822179
• Report Number: 8030229-2019-00722
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 04931921114131
• UDI-Public: 04931921114131
• Combination Product (y/n): N
• PMA/PMN Number: K102376
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 03/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2019
• 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
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/25/2020
• Distributor Facility Aware Date: 03/24/2020
• Device Age: 54 MO
• Event Location: Hospital
• Date Report to Manufacturer: 03/25/2020
• Date Manufacturer Received: 03/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1