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

Model Number CNS-6201A

Device Problems Image Display Error/Artifact (1304); Output Problem (3005)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/18/2019

Event Type  malfunction  

Manufacturer Narrative

The customer was able to resolve the issue before nihon kohden technical services was able to return their call, but later reported that there was an interruption in monitoring while the bme fixed the issue.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.Additional model information: the cns was monitoring bedside monitors, but no model information was provided.

Event Description

The biomedical engineer (bme) reported that the central nurse's station (cns) screen was displaying backwards, which was later determined to mean that the tiles were not in the correct order.

Event Description

The biomedical engineer (bme) reported that the central nurse's station (cns) screen was displaying backwards, which was later determined to mean that the tiles were not in the correct order.

Manufacturer Narrative

Details of the complaint on (b)(6) 2019, (b)(6) health reported the cns-6201a (pu-621ra sn: (b)(6) screen was backwards.This was caused because she had to shut down the system to replace a bad ups and upon boot up, the displays were backwards.Service requested troubleshooting/assistance.Service performed customer resolved the issue by changing settings to correct the order of the monitors displayed.Investigation result the device warranty began 04/23/2015, and the reported issue occurred after 3 years with customer.Review of device sap history found no previously reported issues with the cns display.There was a loss of cns display settings after customer had shut down the system.Further details on the method of shutdown and ups which failed was not provided.Based on the available information, the root cause could not be determined.Issue was resolved upon adjusting display settings.No further issues reported for the unit.Similar tickets review of keywords "pu-621ra backward(s)" found no other reported issue."pu-621ra reverse" found one ticket: (b)(4) reported 10/30/2018.Customer reported screen was installed reverse.The root cause was determined to be incorrect install of the system.No adverse trend found for this issue and this issue is not suspected to be caused by deficient design.Additional information: b4.Date of this report.D11& c2 concomitant medical products.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? additional information.H3.Device evaluated by manufacturer? h6.Event problem and evaluation codes.H10.Additional manufacturer narrative.

• 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: 8895597
• MDR Text Key: 200809930
• Report Number: 8030229-2019-00377
• 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: user facility
• Type of Report: Initial,Followup
• Report Date: 10/18/2019

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: 10/18/2019
• Distributor Facility Aware Date: 10/16/2019
• Device Age: 55 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/18/2019
• Initial Date Manufacturer Received: 07/18/2019
• Initial Date FDA Received: 08/14/2019
• Supplement Dates Manufacturer Received: 10/16/2019
• Supplement Dates FDA Received: 10/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BEDSIDES; BEDSIDES