MAUDE Adverse Event Report: NKUS LAB RNS-9703-024; REMOTE NETWORK STATION

Model Number	RNS-9703-024
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported that both remote network stations (rns or remote monitoring system) are experiencing communication loss.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.
Event or Problem Description
The customer reported that both remote network stations (rns or remote monitoring system) are experiencing communication loss.
Event or Problem Description
The customer reported that both remote network stations (rns or remote monitoring system) are experiencing communication loss.
Additional Manufacturer Narrative
The customer reported that both remote network stations (rns or remote monitoring system) are experiencing communication loss.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.This is a resubmission of the follow up 001, per fda request.

• Brand Name: RNS-9703-024
• Common Device Name: REMOTE NETWORK STATION
• Manufacturer (Section D): NKUS LAB; 5 jenner, suite 180; attn.: susan shadley; irvine CA 92618
• MDR Report Key: 5501963
• Report Number: 2032233-2015-00123
• Device Sequence Number: 3878845
• Product Code: MHX
• UDI-Device Identifier: 00851725007016
• UDI-Public: 00851725007016
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: user facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/11/2015

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-9703-024
• Device Catalogue Number: RNS-9703-024
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/11/2015
• Supplement Date Received by Manufacturer: 05/11/2015; 05/11/2015
• Initial Report FDA Received Date: 03/15/2016
• Supplement Report FDA Received Date: 01/15/2021; 03/15/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1