MAUDE Adverse Event Report: Nihon Kohden Digital Health Solutions Inc. NGNK-6803; Next Generation NetKonnect

Model Number	NGNK-6803
Medical Device Problem Codes	Unable to Obtain Readings (1516); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The biomedical engineer (biomed) reported that the ngnk monitor located in the nicu would randomly display a "cannot detect hard drive" error message and subsequently failed to boot.No patient harm was reported.
Additional Manufacturer Narrative
Details of complaint: the biomedical engineer (bme) reported that the ngnk monitor located in the nicu would randomly display a "cannot detect hard drive" error message and subsequently failed to boot.They attempted to clear the error and restore the device by rebooting the ngnk several times, but the issue persisted.This device was on the 4th floor, and the associated cns was on the 5th floor, making it difficult to monitor critical nicu patients locally, thus affecting ongoing patient monitoring activities.Technical support (ts) had them reboot the device while all peripheral devices were disconnected to determine if it would boot properly.After waiting about 5 minutes, the device was still frozen at the dell loading screen.No patient harm was reported.Investigation summary: the device was returned to nihon kohden for evaluation and repair.During evaluation, the reported failure was successfully duplicated, confirming a boot failure associated with the hard drive.A physical inspection found no visible physical damage or signs of liquid intrusion.However, a dim spot larger than 2 inches was observed on the lower portion of the display screen.The root cause was determined to be a defective hard drive that prevented the device from completing the boot process.Due to the hard drive failure, display defect, failure to meet qc inspection requirements, and out-of-warranty status, the device was determined to be unrepairable and will be scrapped.Nihon kohden will continue to trend and monitor.Additional information: b4 date of this report d9 device available for evaluation? 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: NGNK-6803
• Common Device Name: Next Generation NetKonnect
• Manufacturer (Section D): Nihon Kohden Digital Health Solutions Inc.; attn: shama mooman; 14 bunsen; irvine CA 92618
• Manufacturer (Section G): Nihon Kohden Digital Health Solutions Inc.; attn: shama mooman; 14 bunsen; irvine CA 92618
• Manufacturer Contact: shama mooman ; attn: shama mooman; 14 bunsen; irvine, CA 92618 ; +1(949)268-7488
• MDR Report Key: 50011241
• Report Number: 8030229-2026-06897
• Device Sequence Number: 8366791
• Product Code: MHX
• UDI-Device Identifier: 00851725007306
• UDI-Public: (01)00851725007306
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K220989
• 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,Followup
• Report Date (Section B): 10/02/2026

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: NGNK-6803
• Device Catalogue Number: NGNK-6803
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/09/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2026
• Supplement Date Received by Manufacturer: 09/24/2026
• Initial Report FDA Received Date: 07/27/2026
• Supplement Report FDA Received Date: 10/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/28/2022
• 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
• Patient Sex: Unknown