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

Model Number CNS-6201A

Device Problems Display or Visual Feedback Problem (1184); Image Display Error/Artifact (1304); Human-Device Interface Problem (2949); Output Problem (3005)

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

Event Date 11/20/2019

Event Type  malfunction  

Manufacturer Narrative

The customer reported that they were not able to see waveforms on the dual display on the central nursing station (cns).Tabs were overlapping, making the windows barely visible.This cns was a spare for the hospital.There was another cns in place monitoring the patients.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 when additional information becomes available.The following field contains no information (ni), as attempts to obtain information were made, but not provided: concomitant medical device.

Event Description

The customer reported that they were not able to see waveforms on the dual display on the central nursing station (cns).Tabs were overlapping, making the windows barely visible.This cns was a spare for the hospital.There was another cns in place monitoring the patients.No patient harm was reported.

Manufacturer Narrative

Details of the complaint: on (b)(6) 2019, customer at honor health reported they were unable to view the monitor in tile at cns on pu621ra with serial# (b)(6) service requested: assistance in troubleshooting.Service performed: nkts could duplicate the issue and assisted in troubleshooting.The issue was resolved by interchanging the dvi and vga cables between main display and second display.Nkts educated customer that dvi cable should always be connected to the main display and vga should be on the secondary display, however customer had it vice versa.The root cause of the issue was user error due to incorrect placing of dvi and vga cables from the main and second display of the cns.The issue was resolved.Investigation result: the root cause of the issue was user error due to incorrect placing of dvi and vga cables from the main and second display of the cns.The warranty of the device expired on 10/30/2018.Review of device history found no similar reported issue on the device.The following field contains no information (ni), as attempts to obtain information were made, but not provided: d11 & c2.Concomitant medical device.Additional information: b4.Date of this report.F6.Date user facility/importer became aware of the event.F7.Type of report.F11.Date report sent to fda.F13.Date report sent to manufacturer.G4.Date received by manufacturer.G7.Type of report.H2.If follow-up, what type? h6.Event problem and evaluation codes.H10.Additional manufacturer narrative.

Event Description

The customer reported that they were not able to see waveforms on the dual display on the central nursing station (cns).Tabs were overlapping, making the windows barely visible.This cns was a spare for the hospital.There was another cns in place monitoring the patients.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: 9477826
• MDR Text Key: 200812223
• Report Number: 8030229-2019-00718
• 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: 01/24/2020

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
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/24/2020
• Distributor Facility Aware Date: 01/20/2020
• Device Age: 46 MO
• Event Location: Hospital
• Date Report to Manufacturer: 01/24/2020
• Initial Date Manufacturer Received: 11/20/2019
• Initial Date FDA Received: 12/17/2019
• Supplement Dates Manufacturer Received: 01/20/2020
• Supplement Dates FDA Received: 01/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1