MAUDE Adverse Event Report: NIHON KOHDEN DIGITAL HEALTH SOLUTIONS INC. REMOTE NETWORK STATION; REMOTE MONITORING STATION

Model Number	RNS-6803-7460
Medical Device Problem Codes	Device Alarm System (1012); Protective Measures Problem (3015)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The biomedical engineer (bme) reported that the remote network station (rns) did not alarm for a patient's ventricular tachycardia.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.The following field contains no information (ni), as attempts to obtain the information were made, but not provided: d10 attempt # 1: 07/23/2025 emailed the bme for all information in the ni list above: no reply was received.Attempt # 2: 07/28/2025 emailed the bme for all information in the ni list above: no reply was received.Attempt # 3: 08/04/2025 emailed the bme for all information in the ni list above: no reply was received.
Event or Problem Description
The biomedical engineer (bme) reported that the remote network station (rns) did not alarm for a patient's ventricular tachycardia.No patient harm was reported.
Additional Manufacturer Narrative
Details of complaint: the biomedical engineer (bme) reported that the remote network station (rns) did not alarm for a patient's ventricular tachycardia.No patient harm was reported.Investigation summary: insufficient information / no product returned: multiple attempts were made to collect additional information regarding the complaint.However, there has been no response from the customer.There is not enough information to perform an investigation.Complaint history review for the rns-6803/6804 did not show any trends for this issue.Nk will continue to monitor and trend.Additional information: b4 date of this report.G3 date received by manufacturer.G6 type of report.H2 if follow-up, what type? h6 event problem and evaluation codes.H11 additional manufacturer narrative.
Event or Problem Description
The biomedical engineer (bme) reported that the remote network station (rns) did not alarm for a patient's ventricular tachycardia.No patient harm was reported.

• Brand Name: REMOTE NETWORK STATION
• Common Device Name: REMOTE MONITORING STATION
• 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 ; 9492687488
• MDR Report Key: 22795597
• Report Number: 8030229-2025-05344
• Device Sequence Number: 15655616
• Product Code: MHX
• UDI-Device Identifier: 00851725007184
• UDI-Public: (01)00851725007184
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K102376
• 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): 11/06/2025

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: RNS-6803-7460
• Device Catalogue Number: RNS-6803-7460
• 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: 07/16/2025
• Supplement Date Received by Manufacturer: 10/27/2025
• Initial Report FDA Received Date: 08/13/2025
• Supplement Report FDA Received Date: 11/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/03/2019
• 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