MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION CNS-2101 CENTRAL MONITOR; CENTRAL MONITORING SYSTEM

Model Number	CNS-2101
Medical Device Problem Code	Unintended Application Program Shut Down (4032)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/08/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The biomedical engineer (bme) reported that the central nurse station (cns) spontaneously rebooted on june 1st around 13:52 and again on june 7th around 13:50.They would like the logs reviewed.No reports of patient harm.
Additional Manufacturer Narrative
Details of complaint: the biomedical engineer (bme) reported that the central nurse station (cns) spontaneously rebooted on june 1st around 13:52 and again on june 7th around 13:50.They would like the logs reviewed.No reports of patient harm.Investigation summary: based on the results of the investigation, there is no evidence of a rebooting event on june 1st, 2026.However, the logs show an unexpected system shutdown at 1:46:14 pm on 06/07/2026.Based on the available log data, the reboot may have been triggered by a system crash or an unexpected loss of power.In addition, the event log indicates that the device has been operating continuously for more than eight months.According to the service manual, the central monitor should be restarted at least once every six months to ensure stable operation.Although there was a patient involved, there were no reports of injury, no harm, nor any adverse events, due to the reported issue.Trending will continue to be monitored for this device, incidents, issues, and causes.

• Brand Name: CNS-2101 CENTRAL MONITOR
• Common Device Name: CENTRAL MONITORING 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: 25682073
• Report Number: 8030229-2026-06742
• Device Sequence Number: 4643912
• Product Code: MHX
• UDI-Device Identifier: 04931921017159
• UDI-Public: (01)04931921017159
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K223567
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 07/01/2026

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
• Operator of Device: Health Professional
• Device Model Number: CNS-2101
• Device Catalogue Number: CNS-2101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2026
• Initial Report FDA Received Date: 07/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/17/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown