MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION CNS-6801A; CENTRAL MONITOR SYSTEM

Model Number CNS-6801A

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

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

Event Date 01/24/2024

Event Type  malfunction  

Event Description

The unit secretary reported that the central nurse's station (cns) is stuck on a screen saying "there was an error with your pc," and would not go past it.When this screen came up, the software shut off, and they cannot see their patients.She does not know if they were monitoring patients at the time because they were not there when it happened.They also tried to get a hold of their biomedical engineer (bme) team, but no one responded back to them.Tech support (ts) had her try to power off the cns and power it back on, but it came up saying "no operating system found." at this point, ts informed them to get their bme team involved because it appears there is an issue with the hdds.It is unknown if the device was in patient use.

Manufacturer Narrative

The unit secretary reported that the central nurse's station (cns) is stuck on a screen saying "there was an error with your pc," and would not go past it.When this screen came up, the software shut off, and they cannot see their patients.She does not know if they were monitoring patients at the time because they were not there when it happened.They also tried to get a hold of their biomedical engineer (bme) team, but no one responded back to them.Tech support (ts) had her try to power off the cns and power it back on, but it came up saying "no operating system found." at this point, ts informed them to get their bme team involved because it appears there is an issue with the hdds.It is unknown if the device was in patient use.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 customer reported that the central nurse's station (cns) was stuck on a screen displaying a "there was an error with your pc" error and would not fully load.When this error displayed, the software closed with no visibility to the patients.They were unsure if patients were being monitored at the time.

Manufacturer Narrative

Details of complaint: the customer reported that the central nurse's station (cns) was stuck on a screen displaying a "there was an error with your pc" error and would not fully load.When this error displayed, the software closed with no visibility to the patients.They were unsure if patients were being monitored at the time.Investigation summary: technical support (ts) had her try to power off the cns and power it back on, but it came up with a "no operating system found" error message.Ts informed them they should get their biomedical engineering (bme) team involved because it appeared there was an issue with the hdds.The complaint device was received by nk on (b)(6) 2024.The unit was evaluated on (b)(6) 2024 and the complaint was duplicated.The hard drives were replaced, and the cns was able to boot up properly.The device completed extended testing and operated to manufacturer's specification.The device was returned to the customer on (b)(6) 2024.Further recurrence has not been reported.The cause of the issue was hard drive failure, which can occur due to physical damage from mishandling, electrical damage from outages or surges, or wear-and-tear which depends on device age and frequency of use.The cns operator's manual recommends periodic replacement of the hdds as they have an expected lifespan of 2 years.Review of the complaint device's serial number shows that the device was installed in 2022 and does not have other similar complaints.A review of the customer's complaint history does not show any trends for these issues.Nk will continue to monitor and trend similar complaints.Additional information: b4 date of this report g3 date received by manufacturer g6 type of report h2 if follow-up, what type? h3 device evaluated by manufacturer? h6 event problem and evaluation codes h11 additional manufacturer narrative.

• Brand Name: CNS-6801A
• 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: 18751999
• MDR Text Key: 336746374
• Report Number: 8030229-2024-04150
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 04931921131640
• UDI-Public: 04931921131640
• 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: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 04/25/2024

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-6801A
• Device Catalogue Number: PU-681RA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/21/2024
• Supplement Dates Manufacturer Received: 04/23/2024
• Supplement Dates FDA Received: 04/25/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/12/2021
• 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