MAUDE Adverse Event Report: NKUS LAB RNS-6803-3464; REMOTE NETWORK STATION

Model Number	RNS-6803-7450
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported that some of their beds are disappearing from the all beds screen on 2 of their remote network system (rns) that are connected to the same, newly installed, crc.Their cns continues working as intended.No harm or injury was reported.Nk ts is currently working on resolivng the issue.Nihon kohden continues to investigate the reported event.Nihon kohden will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.The following fields are not applicable (na) to this report: the following fields contains no information (ni), as attempts to obtain information were made, but not provided.Additional model information: d10 concomitant medical device: the following devices was also affected: remote network system (rns): model: a/rns-6803 sn: (b)(4).The following devices were used in conjuction witht eh affected rns's.The fields contains no information (ni), as attempts to obtain information were made, but not provided.Multiple bedside monitors (bsm's): model: ni sn:(b)(4).
Event or Problem Description
The customer reported that some of their beds are disappearing from the all beds screen on 2 of their remote network system (rns) that are connected to the same, newly installed, crc.
Event or Problem Description
The customer reported that some of the bedside monitors (bsms) were disappearing from the all beds screen on 2 remote network stations (rnss) that were connected to the same, newly installed, crc.
Additional Manufacturer Narrative
Details of complaint: the customer reported that some of the bedside monitors (bsms) were disappearing from the all beds screen on 2 remote network stations (rnss) that were connected to the same, newly installed, crc.The cns and older rnss continued working as intended.No patient harm or injury was reported.Investigation summary: as the reported device was not returned for evaluation, a root cause cannot be determined.Possible causes, as noted by nihon kohden technical support (nk ts), are duplicated packets in the multicast data, or there were multiple gateways in the network, or the enterprise gateway (eg) actually sent the commands 4 times.The customer later stated that the ticket could be closed and reported no further issues.The complaint history review of the reported device shows no evidence of recurrence.The event is unlikely to be related to an nk device malfunction.The root cause is most likely related to the customer's network environment.Communication loss may occur due to issues with the customer's network environment.Network access point overload may cause an unstable network connection and may cause devices to randomly drop connection.Communication loss may also occur after a power loss, as the network server may not properly boot up after an unexpected shutdown.The rns is not the primary patient bedside monitor and does not affect the bedside monitor's ability to monitor the patient or alarm.

• Brand Name: RNS-6803-3464
• Common Device Name: REMOTE NETWORK STATION
• Manufacturer (Section D): NKUS LAB; 14 bunsen; attn: shama mooman; irvine CA 92618
• Manufacturer (Section G): NKUS LAB; 14 bunsen; attn: shama mooman; irvine CA 92618
• Manufacturer Contact: shama mooman ; 14 bunsen; irvine, CA 92618 ; 9492687488
• MDR Report Key: 11103561
• Report Number: 2032233-2019-00804
• Device Sequence Number: 607633
• Product Code: MHX
• UDI-Device Identifier: 00851725007139
• UDI-Public: 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: Other,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2023

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-6803-7450
• Device Catalogue Number: RNS-6803-7450
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2020
• Supplement Date Received by Manufacturer: 02/28/2023
• Initial Report FDA Received Date: 01/01/2021
• Supplement Report FDA Received Date: 03/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/23/2019
• 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
• Concomitant Medical Products and Therapy/Usage Dates: MULTIPLE BEDSIDE MONITORS (BSM'S).; MULTIPLE BEDSIDE MONITORS (BSM'S).; REMOTE NETWORK SYSTEM (RNS).; REMOTE NETWORK SYSTEM (RNS).
• Patient Sex: Unknown