MAUDE Adverse Event Report: NIHON KOHDEN DIGITAL HEALTH SOLUTIONS INC. RNS-6803-3464; REMOTE MONITORING STATION

Model Number	RNS-6803-3464
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The biomedical engineer (bme) requested help with his remote network station (rns) caliper measurements, noting discrepancies between heart rate (hr) readings on the rns and central nurse's station (cns) for a specific patient.Despite attempts to restart monitoring and verify the ip address, the issue persisted.Technical support (ts) included nk clinical support (cas) on the call, who confirmed that no settings should cause this problem, and attempts to copy settings from other beds were unsuccessful.After rebooting the rns, incorrect measurements continued.Biomed advised nursing staff to rely on cns data until the patient is discharged.Cas reported that the heart rate on the cns was around 100, but the rns was showing in the 60s.Somewhere between a 30-40 point difference was what was relayed to them.This was only on that one patient.The heart rate was said to be stable at around 100.They did not have any rates below 98 from what they were relaying.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: (b)(6) 2025 emailed the bme for all information in the ni list above: no reply was received.Attempt # 2: (b)(6) 2025 emailed the bme for all information in the ni list above: no reply was received.Attempt # 3: (b)(6) 2025 emailed the bme for all information in the ni list above: the bme replied that they have not heard anything else from the nursing staff regarding the issue.None of the requested information was provided.
Event or Problem Description
The biomedical engineer (bme) requested help with his remote network station (rns) caliper measurements, noting discrepancies between heart rate (hr) readings on the rns and central nurse's station (cns) for a specific patient.No patient harm was reported.
Event or Problem Description
The biomedical engineer (bme) requested help with his remote network station (rns) caliper measurements, noting discrepancies between heart rate (hr) readings on the rns and central nurse's station (cns) for a specific patient.No patient harm was reported.
Additional Manufacturer Narrative
Details of complaint: the biomedical engineer (bme) requested help with his remote network station (rns) caliper measurements, noting discrepancies between heart rate (hr) readings on the rns and central nurse's station (cns) for a specific patient.Despite attempts to restart monitoring and verify the ip address, the issue persisted.Technical support (ts) included nk clinical support (cas) on the call, who confirmed that no settings should cause this problem, and attempts to copy settings from other beds were unsuccessful.After rebooting the rns, incorrect measurements continued.Biomed advised nursing staff to rely on cns data until the patient is discharged.Cas reported that the heart rate on the cns was around 100, but the rns was showing in the 60s.Somewhere between a 30-40 point difference was what was relayed to them.This was only on that one patient.The heart rate was said to be stable at around 100.They did not have any rates below 98 from what they were relaying.No patient harm was reported.Investigation summary: insufficient information, and no product was 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.Nk will continue to monitor and trend.The following field contains no information (ni), as attempts to obtain the information were made, but not provided: d10 attempt # 1: 04/01/2025 emailed the bme for all information in the ni list above: no reply was received.Attempt # 2: 04/04/2025 emailed the bme for all information in the ni list above: no reply was received.Attempt # 3: 04/10/2025 emailed the bme for all information in the ni list above: the bme replied that they have not heard anything else from the nursing staff regarding the issue.None of the requested information was provided.Additional device information: d10 concomitant medical device: the following device was used in conjunction with the rns: cns: model #: ni.Serial #: ni.Device manufacturer data: ni.Unique identifier (udi) #: ni.Returned to nihon kohden: na.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.

• Brand Name: RNS-6803-3464
• 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: 21915656
• Report Number: 8030229-2025-04898
• Device Sequence Number: 18321229
• Product Code: MHX
• UDI-Device Identifier: 00851725007139
• UDI-Public: (01)00851725007139
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 07/18/2025

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-6803-3464
• Device Catalogue Number: RNS-6803-3464
• 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: 03/28/2025
• Supplement Date Received by Manufacturer: 07/08/2025
• Initial Report FDA Received Date: 04/26/2025
• Supplement Report FDA Received Date: 07/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/18/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CNS.; CNS.
• Patient Sex: Unknown