MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION CNS-6801A; CENTRAL MONITOR SYSTEM

Model Number CNS-6801A

Device Problems Signal Artifact/Noise (1036); Display or Visual Feedback Problem (1184); Image Display Error/Artifact (1304)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/12/2019

Event Type  malfunction  

Manufacturer Narrative

The customer reported that the central nurse's station (cns) showed artifacts/noise on all 4 bed tiles.No consequence or impact to the patient.Nihon kohden is currently working to resolve the issue with the customer.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.Additional device information: concomitant medical devices: the following devices were being used in conjunction with the cns: tele devices: no models and serial numbers were provided.

Event Description

The customer reported that the central nurse's station (cns) showed artifacts/noise on all 4 bed tiles.No consequence or impact to the patient.

Manufacturer Narrative

Details of the complaint: on (b)(6) 2019, customer at (b)(6) hospital reported a cns (pu-681ra sn: (b)(6) was experiencing noise / artifact on all bed tiles.The system was recently installed three weeks prior.Service requested: troubleshooting / assistance.Service performed: nka technical support (ts) discovered the customer was using org-9100 with old software version 01-10.Once all three org-9100 were upgraded to version 04-20, customer reported ecg waveforms were significantly improved.Investigation conclusion: software updates add many key features which provide increased functionality and usability than previous software versions.It is important that the customer utilizes the nihon kohden patient monitoring system lifetime software update program to benefit from improved functions and ensure compatibility of products.The root cause is determined to be continued use of early version org software.Issue was resolved upon upgrading of the org software to version 04-20.No risk assessment is performed as the reported issue is not suspected to involve a device non-conformance.Additional device information: d11 & c2 concomitant medical devices: the following devices were being used in conjunction with the cns: tele devices: no models and serial numbers were provided.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 the central nurse's station (cns) showed artifacts/noise on all 4 bed tiles.No consequence or impact to the patient.

• Brand Name: CNS-6801A
• 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: 9541714
• MDR Text Key: 204417415
• Report Number: 8030229-2020-00004
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 04931921131640
• UDI-Public: 04931921131640
• 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: 03/27/2020

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-6801A
• Device Catalogue Number: PU-681RA
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/27/2020
• Distributor Facility Aware Date: 03/25/2020
• Device Age: 12 MO
• Event Location: Hospital
• Date Report to Manufacturer: 03/27/2020
• Initial Date Manufacturer Received: 12/12/2019
• Initial Date FDA Received: 01/02/2020
• Supplement Dates Manufacturer Received: 03/25/2020
• Supplement Dates FDA Received: 03/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TELES; TELES