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

Model Number CNS-9700A

Device Problems No Display/Image (1183); Output Problem (3005)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/03/2022

Event Type  malfunction  

Event Description

The nurse reported that the central nurse's station (cns) went to a blue screen, then shut off, and when it came back on, it has a message "no video input" while monitoring telemetry patients, so they are completely down and cannot see the patients on the cns.The nurse reported that they have another cns in another department that they can pull the telemetry's up on to continue monitoring the patients for the time being.No patient harm was reported.Nihon kohden technician advised the nurse that this cns is at the end of its service/support/life and it may have bad hard drives/ graphic cards that is causing the issue.Nk technician made some suggestions to try and resolve their issue at the time of the call but the nurse was not able to do the troubleshooting at the time and will get with their biomed to figure out what to do next.

Manufacturer Narrative

Concomitant medical device: the following device(s) was used in conjunction with the cns: telemetry: model #: ni, serial #: ni.

Event Description

The nurse reported that the central nurse's station (cns) went to a blue screen, then shut off, and when it came back on, it has a message "no video input" while monitoring telemetry patients, so they are completely down and cannot see the patients on the cns.The nurse reported that they have another cns in another department that they can pull the telemetry's up on to continue monitoring the patients for the time being.No patient harm was reported.Nihon kohden technician advised the nurse that this cns is at the end of its service/support/life and it may have bad hard drives/ graphic cards that is causing the issue.Nk technician made some suggestions to try and resolve their issue at the time of the call but the nurse was not able to do the troubleshooting at the time and will get with their biomed to figure out what to do next.

Manufacturer Narrative

The nurse reported that the central nurse's station (cns) went to a blue screen, then shut off, and when it came back on, it has a message "no video input" while monitoring telemetry patients, so they are completely down and cannot see the patients on the cns.The nurse reported that they have another cns in another department that they can pull the telemetry's up on to continue monitoring the patients for the time being.No patient harm was reported.Nihon kohden technician advised the nurse that this cns is at the end of its service/support/life and it may have bad hard drives/ graphic cards that is causing the issue.Nk technician made some suggestions to try and resolve their issue at the time of the call but the nurse was not able to do the troubleshooting at the time and will get with their biomed to figure out what to do next.Investigation summary: no video input error occurs when the monitor is not able to connect to a device.Attempts to collect information from the customer regarding the issue have gone unanswered.As such, root cause cannot be determined.Likely causes for this error is most likely related to hardware or cable failure.Possible hardware that could contribute to "no video input" error are the cns components and the keyboard/video/mouse (kvm) switch box.The customer was using a kvm solution in order to extend their display into a separate monitor.The customer was advised by nihon kohden technical support to bypass the kvm and connect the monitor directly to the cns tower.No further issues reported.Direct connection has most likely resolved the issue indicating the kvm may have failed.As the kvm was not returned for evaluation, the most likely root causes for kvm failure are physical damage and normal wear and tear.As the cns reported in this complaint was installed in 01/2011, it is likely that the kvm failed due to aging.The overall risk score of medium a corrective and preventative action (capa) is not warranted as the issue could not be confirmed to be a result of a nihon kohden device malfunction.The following fields are not applicable (na) to this report: d4 lot # & expiration date.G4 device bla number.The following fields contain no information (ni), as attempts to obtain information were made, but not provided: attempt # 1: 02/10/2022 emailed the nurse who reported the incident via microsoft outlook for the no information (ni) above: email address incorrect and email was returned as undeliverable.Attempt # 2: 02/17/2022 called and spoke with someone at hospital who had no knowledge of this incident but they provided a valid email for the nurse who reported this incident.Attempt # 3: 02/17/2022 emailed the nurse via microsoft outlook for no information reported above and no reply was received.Additional device information: d10 concomitant medical device: the following device(s) was used in conjunction with the cns: telemetry: model #: ni.Serial #: ni.Additional narrative/data: b4 date of this report.G3 date received by manufacturer.G6 type of report.H2 if follow-up, what type?.

• Brand Name: CNS-9700A
• Type of Device: CENTRAL MONITOR SYSTEM
• Manufacturer (Section D): NIHON KOHDEN CORPORATION; attn: shama mooman; 1-31-4 nishiochia; shinjuku-ku, tokyo 161-8 560; JA 161-8560
• Manufacturer (Section G): NIHON KOHDEN TOMIOKA CORPORATION; attn: shama mooman; 1-1 tajino; tomioka city, gunma 370-2 314; JA 370-2314
• Manufacturer Contact: shama mooman ; safety mgmt dept, quality mgmt; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa,, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 13592717
• MDR Text Key: 286134354
• Report Number: 8030229-2022-02557
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 04931921000663
• UDI-Public: 04931921000663
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K023475
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/23/2022

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/03/2022
• Initial Date FDA Received: 02/24/2022
• Supplement Dates Manufacturer Received: 05/17/2022
• Supplement Dates FDA Received: 05/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/24/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: TELEMETRY; TELEMETRY