MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION CNS-9700A; CENTRAL MONITOR SYSTEM

Model Number CNS-9700A

Device Problems Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138); No Display/Image (1183); Device Inoperable (1663)

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

Event Date 02/13/2018

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer reported that the display on the central nurse's station (cns) was blank.Nihon kohden technical support secialist provided the biomedical engineer with some troubleshooting tips, including checking the cable connections and swapping the graphic cards.Once this was performed, the display came back up again.The device will not be returned for evaluation.No patient harm was reported.

Event Description

The biomedical engineer reported that the display on the central nurse's station (cns) was blank.

Manufacturer Narrative

H10: additional narrative: on (b)(6) 2018, bme (b)(6) at (b)(6) hospital reported the cns-9701a (mu-971ra sn: (b)(6) display was not working and only showed blank black.Service requested: troubleshooting/assistance.Service performed: bme swapped graphics card and the display came back.Investigation result: the cns was put into service on 02/11/2009, which is 9 years prior to the reported issue.The warranty ended on 02/11/2011.A review of cns service history found no previously reported issues with the unit's display.There was a suspected failure of the cns graphic board.If the graphic board was not replaced during the cns's lifetime, this would indicate the board was 9 years of age.During this time, factors such as age, use, and conditions at the facility could contribute to degradation of the cns and its parts.Per cns-9701a service manual rev.E, customer is advised to perform maintenance check on the unit once every six months.Information on if this was regularly performed is unknown.Review of device history found no nka servicing performed on the unit.Troubleshooting of the cns display problem, along with proper action to take, is addressed in the cns-9701a service manual.The service manual also outlines steps to replace the graphic board in steps 1 and 2 of "replacing the motherboard".Per nkc dhr, the unit has had no history of ncmr, deviation, or capa during manufacturing of the device.The device has not been refurbished and there were no discrepancies or unusual findings before device release that might relate to the reported issue.This issue is not suspected to be caused by a deficiency during manufacturing of the device.The cns-9701a model was discontinued on 11/14/2011 in mbg-111114 due to the introduction of cns-6201a central station.Support for the unit continued for a minimum period of seven years.The graphic card failed well beyond the warranty period and toward the end of the promised support period.The cns/graphic card was not returned, and no nka evaluation was performed.The condition of the part is unknown.Customer was able to resolve the issue by replacing the graphic board.There were no further reported issues with the cns.Based on the given information, this issue is not suspected to be caused by deficient design.Corrected information: g4.Date received by manufacturer: should be 02/13/2018 not 03/14/2018 as listed on mdr initial report.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? correction.Additional information.H3.Device evaluated by manufacturer? h6.Event problem and evaluation codes.H10.Additional manufacturer narrative.

Event Description

The biomedical engineer reported that the display on the central nurse's station (cns) was blank.

• Brand Name: CNS-9700A
• 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: 7340081
• MDR Text Key: 102467816
• Report Number: 8030229-2018-00069
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 04931921000663
• UDI-Public: 04931921000663
• Combination Product (y/n): N
• PMA/PMN Number: K023475
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 07/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CNS-9700A
• Device Catalogue Number: MU-971RA
• Device Lot Number: NOT APPLICABLE
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/29/2019
• Distributor Facility Aware Date: 07/29/2019
• Device Age: 113 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/29/2019
• Date Manufacturer Received: 07/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NOT APPLICABLE
• Patient Sequence Number: 1