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

Model Number CNS-6201A

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/27/2019

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer reported that the one of the displays failed on the dual display set up for the central nurse's station (cns) while monitoring patients.No patient harm 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 biomedical engineer reported that the one of the displays failed on the dual display set up for the central nurse's station (cns) while monitoring patients.No patient harm reported.

Event Description

The biomedical engineer reported that the one of the displays failed on the dual display set up for the central nurse's station (cns) while monitoring patients.No patient harm reported.

Manufacturer Narrative

Complaint details: the customer reported on (b)(6) 2019 that the display on one cns failed with a dual display setup.Service requested: troubleshooting.Service provided: troubleshooting.Investigation result: the pu-621ra; sn: (b)(6) was placed into service on 01/17/2013, which is over 6 years at the time of the reported issue.A review of device history found no the following issues with the cns display: 300004174 reported on 11/21/2014- main display is dark; root cause: unknown 300068915- lcd on monitor is going out; root cause: defective cable 300113241- secondary monitor does not have touch capability; root cause: user error similar tickets using "pu-621ra failed cns display" gave the following result: 14217- display settings failed error message; root cause: unknown 15600- display went out; root cause: unknown 44067- failed secondary display port; root cause/ cause: hd failure 48228- display settings failed; root cause: user error 21381- display failed; root cause: unknown based on the device service history and similar search query, no adverse trend is suspected with this device.The cause of the issue was determined to be hd failure.The root cause of the issue was unable to be determined.The issue was resolved by replacing the hd.The cns-6201a service manual recommends regular maintenance/periodic inspection every 6 months on the unit, which may detect degradation or loss of function of the unit.Performance and degradation of the hdds is affected by several factors such as storage, handling, use, and power conditions.The cns-6201a operator's manual provides the customer with recommended use, storage, and handling of the device.Hdds are a replaceable part and are to be replaced when they fail and the service manual addresses replacement of hdds.The device service record shows that there have been no further/previously reported issues nor servicing for "cns down, not booting into the windows." the unit was installed in 2013 and the complaint was made 4 years after the end of warranty date.Additional information: b4.Date of this report.D10.Device available for evaluation? 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.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: 8642666
• MDR Text Key: 146356304
• Report Number: 8030229-2019-00175
• 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: 10/25/2019

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
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2019
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/25/2019
• Distributor Facility Aware Date: 10/24/2019
• Device Age: 80 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/25/2019
• Initial Date Manufacturer Received: 04/27/2019
• Initial Date FDA Received: 05/24/2019
• Supplement Dates Manufacturer Received: 10/24/2019
• Supplement Dates FDA Received: 10/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NOT APPLICABLE
• Patient Sequence Number: 1