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

Model Number CNS-6801A

Device Problems Computer Operating System Problem (2898); Unintended Application Program Shut Down (4032)

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

Event Date 12/21/2023

Event Type  malfunction  

Manufacturer Narrative

The customer reported that both hard drives (hdds) for the central nurses station (cns) failed.Technical support noted initially that only one (1) hdd failed, so we did an exchange for a blank hdd yesterday (12/19/2023) under 300352989, but since the backup hdd crashed, they could not use the blank hdd we sent.They will send in this cns for repair.No patient harm was 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 customer reported that both hard drives (hdds) for the central nurses station (cns) failed.No patient harm was reported.

Manufacturer Narrative

Details of complaint: the customer reported that both hard drives (hdds) for the central nurses station (cns) failed.Technical support noted initially that only one (1) hdd failed, so we did an exchange for a blank hdd yesterday (12/19/2023) under 300352989, but since the backup hdd crashed, they could not use the blank hdd we sent.They will send in this cns for repair.No patient harm was reported.Investigation summary: upon evaluation from the repair center, they found the cns to no longer being operational.The reported issue was not duplicated due to the hdds not in fact failing.As such, a definitive root cause could not be determined.However, repair center found the device's mother board pcb was malfunctioning.When the mother pcb malfunctions, the symptoms look like hdd failure because the mother pcb could not detect the hdds.Other potential startup related issues or errors can arise due to issues with the ups, malfunction of hdd components, improper software registrations, and improper connection of cables.Other causes include sudden shutdowns, faulty network switches, overheating due to clogged fans with dust or debris, and duplicate ip addresses.Continuous restarts of the cns may be caused by device driver issues, screen resolution errors, windows update issues, or corrupt registry entries.Black and blue screens may indicate disk corruption or a lack of free space, memory problems, or hard drive faults.To ensure correct device function, users should ensure devices are properly seated to all other devices and connected to power supplies, and in case of ups failure, connect devices to alternate power sources.An hdd port error message prompts the user to check the condition of the hdds when it has exceeded 20,000 hrs.Of runtime.Hdd port error messages are not an indication of device failure.To mitigate the risks from hdd failures, the cns is designed with raid (redundant array of independent disks), so that if one hdd fails, another hdd can take over.However, users may replace the hdds or may continue to use the hdd after the inspection of the condition of the hdd.Failure to replace the hdd or inspect the hdd may lead to hdd failure.Labeling and operator's manual for various generations of the cns recommend periodic maintenance or replacement of hard disk drives.A serial number review of the reported device (model: pu-681ra, serial number 2091) reveals one additional related complaint.Complaint history review of the customer's account does not reveal trends for similar complaints.Complaint history review of the customer's account does not reveal trends for similar complaints.Nk will continue to monitor and trend similar complaints.The following fields contain no information (ni), as attempts to obtain the information were made, but not provided: a2 - a6.B6 - b7.D10.Attempt # 1: 12/29/2023 emailed the customer for all items under the no information list.No reply was received.Attempt # 2: 01/08/2024 emailed the customer for all items under the no information list.No reply was received.Attempt # 3: 01/15/2024 emailed the customer for all items under the no information list.No reply was received.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.

Event Description

The customer reported that both hard drives (hdds) for the central nurses station (cns) failed.No patient harm was reported.

• 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: 18531057
• MDR Text Key: 333540230
• Report Number: 8030229-2024-04040
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/27/2024

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: 01/08/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/21/2023
• Initial Date FDA Received: 01/17/2024
• Supplement Dates Manufacturer Received: 03/25/2024
• Supplement Dates FDA Received: 03/27/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/27/2021
• 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
• Treatment: NI.; NI.