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

Model Number CNS-6201A

Device Problems Application Program Problem (2880); Application Program Freezes, Becomes Nonfunctional (4031)

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

Event Date 11/29/2023

Event Type  malfunction  

Event Description

The biomedical engineer (bme) reported that the central nurse's station (cns) just returned from repair and the hdds were just replaced in 300352538.They tried setting up the cns; and after assigning a batch of telemetry transmitters (teles), a dialogue box popped up indicating an application error."cns-16x: cns6201.Exe - application error." the dialogue box read, "the instruction at "0x0061af1d" referenced memory at "0x00000000." the memory could not be "read." click on ok to terminate the program.Click on cancel to debug the program." after this dialogue box appears, the background image begins overlapping with itself and becomes nonfunctional.Any subsequent restart of the program prompts the same results.Not in patient use.

Manufacturer Narrative

Details of complaint: the biomedical engineer (bme) reported that the newly returned central nurse's station (cns) from nihon kohen repair center (nk rc), to replace the hdds in ticket (b)(4), had a dialogue box pop up, indicating an application error (the memory could not be read.) when trying to set the cns up with a batch of telemetry transmitters.After this dialogue box appeared, the background image began overlapping with itself, becoming nonfunctional.Any subsequent restart of the program prompted the same results.The device was not in patient use.Investigation summary: nk technical support (ts) advised the customer the device has reached its end of life and many of the parts are hard to come by and may need replacement.Nk ts also advised the customer that we can evaluate this cns again and take a deeper look at the hdds and the other components.However, we advised the customer if the issue is with the main board or any other components, (in the cns cpu itself), we will not be able to repair the device.The customer was then advised to work with their sales representative to find a replacement for this unit.Nk made 3 attempts to follow up with the customer.However, the customer did not respond, and no further issues were reported, nor were any further issues reported.Nk was able to confirm the issue was likely due to wear and tear of the device, due to aging and degradation of the device and its internal components.The device was installed at the facility on 12/27/2013 and the warranty expired on 12/27/2015, indicating the device has aged approximately ten (10) years and three (3) months, and the device has reached its end of life.Aging devices and their components are susceptible to wear and tear damage.A previous complaint, for the same device, similar issue, (reported under ticket # (b)(4).The device was returned, and the customer was provided with a loaner device.Under the previous ticket, nk confirmed the issue was attributed to the hdds needing to be replaced, likely due to wear and tear damage over time.During review of the device history for the reported issue, we found three similar issues, for similar devices (product id: pu-621ra), that occurred at this facility around the same time frame.Similar complaints were discovered over the past year and are as follows: ticket #185651 (reported on 09/11/2023, sn: (b)(6), ticket #186814 (reported on 09/18/2023, sn: (b)(6) and ticket #195730 (reported on 11/29/2023, sn: (b)(6).A review of the device history does not reveal a significant trend that would contribute to component failure that is related to the design or manufacturing of the device.Nk will continue to monitor trends for this device and facility for similar complaint issues.Additional device information: d10 concomitant medical device: the following devices were used in conjunction with the cns, but the serial numbers are listed as ni, as an attempt to obtain the information was made, but not provided: multiple patient receivers (org): model: org-9110a sn: ni telemetry transmitters model: zm-531pa sn: ni attempt #1 12/05/2023 emailed customer via microsoft outlook for all items under the no information section.The customer responded with complaint details, but did not know the serial number information.

Event Description

The biomedical engineer (bme) reported that the newly returned central nurse's station (cns) from nk repair, to replace the hdds in ticket (b)(4), had a dialogue box pop up, indicating an application error (the memory could not be read) when trying to set the cns up with a batch of telemetry transmitters.After this dialogue box appeared, the background image began overlapping with itself, becoming nonfunctional.Any subsequent restart of the program prompted the same results.The device was not in patient use.

• Brand Name: CNS-6201A
• 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 ; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 18419461
• MDR Text Key: 331693173
• Report Number: 8030229-2023-03955
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 04931921114131
• UDI-Public: 04931921114131
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102376
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 03/26/2024

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/29/2023
• Initial Date FDA Received: 12/29/2023
• Supplement Dates Manufacturer Received: 03/25/2024
• Supplement Dates FDA Received: 03/26/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/18/2013
• 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: ORG; ORG-9110A; ZM TELEMETRY TRANSMITTERS; ZM-531PA