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

Model Number CNS-9700A

Device Problems No Display/Image (1183); Display or Visual Feedback Problem (1184); Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/04/2019

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer reported that the display on the central nurse's station (cns) had failed, and there is a streak of dead pixels that run down the center of the display and interferes with patient monitoring.Displays are not repaired and the customer will be purchasing a new one.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 when additional information becomes available.

Event Description

The biomedical engineer reported that the display on the central nurse's station (cns) had failed, and there is a streak of dead pixels that run down the center of the display and interferes with patient monitoring.No patient harm reported.

Event Description

The biomedical engineer reported that the display on the central nurse's station (cns) had failed, and there is a streak of dead pixels that run down the center of the display and interferes with patient monitoring.No patient harm reported.

Manufacturer Narrative

H10: additional narrative: on (b)(6) 2018, (b)(6) at (b)(6) center reported the cns-9701a (mu-971ra, sn: (b)(6) display failed.There was a streak of dead pixels that run down the center of the display.The streaks interfere with patient monitoring.Service requested: troubleshooting/assistance.Service performed: customer was advised to purchase a replacement display as nka does not repair displays and the device was no longer under warranty.Investigation result: the cns was put into service on 05/15/2011, which is approximately 8 years prior to the reported issue.The warranty period ended on 05/15/2013.A review of device history found no previously reported issues with the unit.There was a reported failure of the cns monitor.The part was not returned and no nka evaluation was performed.Information on the monitor, including its age and condition, is not available.Sap device history has no servicing record for this cns.If the monitor had not been replaced during the cns's lifetime, this would indicate the monitor was 8 years of age.During this time, factors such as use, power issues, and other environmental factors at the facility could contribute to degradation of the part.Per cns-9701a service manual revision e, it is recommended that a maintenance check is performed once in every six months.This includes checking the external condition of the unit and its peripheral accessories, as well as checking the display.Similar tickets query using keywords "mu-971ra display" found similarly reported issues at other faculties.In each case, the display had failed well beyond the warranty period.The reported issue involved a failure of the cns display.The cns was working as intended.Issue was to be resolved by replacing the display.There were no further reported issues with the unit.Based on the given information, this issue is not suspected to be caused by deficient design.Corrected information: f9.Approximate age of device: incorrectly calculated.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? additional information.Correction.H6.Event problem and evaluation codes.H10.Additional manufacturer narrative.

• 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: 8656404
• MDR Text Key: 146797432
• Report Number: 8030229-2019-00187
• 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: 07/26/2019

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-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: 07/26/2019
• Distributor Facility Aware Date: 07/24/2019
• Device Age: 102 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/26/2019
• Initial Date Manufacturer Received: 05/04/2019
• Initial Date FDA Received: 05/30/2019
• Supplement Dates Manufacturer Received: 07/24/2019
• Supplement Dates FDA Received: 07/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NOT APPLICABLE
• Patient Sequence Number: 1