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

Model Number CNS-9700A

Device Problems Device Inoperable (1663); Communication or Transmission Problem (2896); Device Operates Differently Than Expected (2913)

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

Event Date 02/23/2018

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer reported a malfunction of the central nurse's station (cns).When monitoring an individual patient, another patient's information appears, and then stops monitoring the original patient.The nurse removed some of the patient names and manually entered them, but the issue persisted.Troubleshooting involved ensuring that the connections were stable, checking the status of the ups, and verifying there are no duplicate ip addresses.It was noted that some of the switches showed reduced speeds.The biomedical engineer also mentioned that the server regularly reboots and that the cns freezes and reboots.The biomedical engineer requested a loaner cns.No patient harm reported.

Event Description

The biomedical engineer reported a malfunction of the central nurse's station (cns).When monitoring an individual patient, another patient's information appears, and then stops monitoring the original patient.

Event Description

The biomedical engineer reported a malfunction of the central nurse's station (cns).When monitoring an individual patient, another patient's information appears, and then stops monitoring the original patient.

Manufacturer Narrative

H10: additional narrative: customer stated patient info pops up on them and stops monitoring the patient.Customer recorded the following incidents: on (b)(6) 2018: 2 sets of twins (set a- two girls and b-girl and boy) in nicu, 11pm, everything good.2am (b)(6): second set of twins, one of those infants (b) ended up being displayed on both monitors of the first set of twins (a).On (b)(6) 2018: 7pm everything was fine, 11pm: baby girl in nicu was displaying an adult patient's info from medsurg (pcu) (hr/nibp)- big problem.On (b)(6) 2018: 7pm: took both babies names from set b off of the monitors because of the issues at hand, she was frustrated and wanted to manually enter that into meditech herself.On (b)(6) 2018 2am: baby boy from set b had baby girl from set a on his monitor.Baby girl from set b had baby girl from set a on her monitor.(so both twins from set b had a baby girl from set a on both monitors).Monitor with power but no patient also showed a baby girl's vital information (unknown if this was from the twins or not).10:24am on (b)(6) 2018: a baby's name changed again- 5th baby changed to "name not found"- displayed vitals but unknown if correct.These are just the cases that they have actual dates and times for, this keeps happening over and over again.Affected depts known: nicu, ed, pcu, icu.In the past, a similar case in the ed occurred.Broad overview of other things that have been happening: · regular rebooting of server.· freezing cns that keeps getting rebooted- coming in for repair with loaner.Something is happening 11pm-2am, (7am is start of shift, 2am is feeding time).Service requested: repair/loaner.Service performed: repair/loaner.Investigation result: nk ts (b)(6) examined the device logs for cns-01012.It was noted that there were 134 entries under event id: (b)(4) between on (b)(6) 2017 to on (b)(6) 2018.Error message: "a duplicate name has been detected on the tcp network.The ip address of the machine that sent the message is in the data.Use nbtstat -n in a command window to see which name is in the conflict state." nk ts determined that the issue most likely stemmed from a duplicate name on the network, and/or a duplicate ip, but most likely a name.Duplicate names/ips can be problematic for any networking environment and cause communication issues between devices.This name change can only be done on a bedside locally in deep settings, or on the cns through the network.As such customer was advised to take the following actions: take a physical inventory of all device names, physical location, ips, and labeling them on the device to indicate this information.Change the default cns password to eliminate any clinical staff from having the ability to cause these types of concerns.The issue seems to be clinically related on the surface from our findings in the logs and possible workflow issues across the network with the staff.[staff education] take inventory on the host table to look for any duplicate names or ips there.This can be done on one cns but should be looked at on both for thoroughness.Nk ts also recommended best networking practice as well as upgrading to the new hl7 gateway server as the current version was no longer supported.These factors may have played a role in the reported issues; however, the definite cause was duplicate names/ip on the network.Although the root cause was not known, because name change could only be done on the bedside deep settings and at the cns through the network, this hints at the clinical workflow being the root cause.Customer was advised of this possibility.Nka repair center's evaluation of the returned mu-971ra serial number: (b)(6) found it was functioning as intended under test environment.This supports network issue identified above.Service history for (b)(6) center (b)(6) shows the issue has not re-occurred.Corrected information: g4.Date received by manufacturer: should be 02/23/2018 not 03/23/2018 as listed on mdr initial report.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.Device evaluation.Correction.H3.Device evaluated by manufacturer? 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: 7366652
• MDR Text Key: 103407453
• Report Number: 8030229-2018-00086
• 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: 08/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2018
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2018
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/26/2019
• Distributor Facility Aware Date: 06/07/2019
• Device Age: 122 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/26/2019
• Date Manufacturer Received: 06/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NOT APPLICABLE
• Patient Sequence Number: 1