MAUDE Adverse Event Report: NKUS LAB RNS-9703-242; REMOTE NETWORK STATION

Model Number	RNS-9703-242
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported that their remote network station (rns) and central network station (cns) are displaying intermittent signal loss for all monitored tele beds.The customer said that this issue usually starts with a single tile showing signal loss after which all tiles start showing the same.No harm or injury 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.Additional device information: concomitant medical device: the following device(s) were used in conjunction with the rns: cns: model #: ni.Serial #: ni.Device manufacturer data: ni.Unique identifier (udi) #: ni.Transmitters: model #: ni.Serial #: ni.Device manufacturer data: ni.Unique identifier (udi) #: ni.
Event or Problem Description
The customer reported that their remote network station (rns) and central network station (cns) are displaying intermittent signal loss for all monitored tele beds.The customer said that this issue usually starts with a single tile showing signal loss after which all tiles start showing the same.No harm or injury was reported.
Additional Manufacturer Narrative
Details of complaint: the customer reported that the remote network station (rns) and central nurse's station (cns) were displaying intermittent signal loss for all monitored telemetry transmitters.The customer said that this issue usually started with a single tile showing signal loss after which all tiles started showing the same.No patient harm was reported.Details of complaint: nihon kohden technical support (nkts) performed troubleshooting actions and determined one of the antenna was not displaying the led light.Nk ts walked the customer through troubleshooting steps and the antenna was replaced.However, the issue persisted.Nk ts suggested replacing a cable, but the customer informed nk ts that the issue resolved on its own without replacing any wmts equipment.The root cause is determined to be the facility's network environment.The most likely cause was external noise interference.A review of the serial number history shows no recurrence of the reported issue.
Event or Problem Description
The customer reported that the remote network station (rns) and central nurse's station (cns) were displaying intermittent signal loss for all monitored telemetry transmitters.The customer said that this issue usually started with a single tile showing signal loss after which all tiles started showing the same.No harm or injury was reported.

• Brand Name: RNS-9703-242
• Common Device Name: REMOTE NETWORK STATION
• Manufacturer (Section D): NKUS LAB; attn: shama mooman; 14 bunsen; irvine CA 92618
• Manufacturer (Section G): NKUS LAB; attn: shama mooman; 14 bunsen; irvine CA 92618
• Manufacturer Contact: shama mooman ; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama, CA 359-8-580 ; JA 359-8580 ; 9492687488
• MDR Report Key: 12723640
• Report Number: 8030229-2021-01881
• Device Sequence Number: 8192361
• Product Code: MHX
• UDI-Device Identifier: 00851725007122
• UDI-Public: 00851725007122
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K023475
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 03/30/2023

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-9703-242
• Device Catalogue Number: RNS-9703-242
• 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: 10/05/2021
• Supplement Date Received by Manufacturer: 03/28/2023
• Initial Report FDA Received Date: 10/29/2021
• Supplement Report FDA Received Date: 03/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/04/2018
• 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: CENTRAL NURSES STATION (CNS).; CENTRAL NURSES STATION (CNS).; MULTIPLE TRANSMITTERS.; MULTIPLE TRANSMITTERS.
• Patient Sex: Unknown