MAUDE Adverse Event Report: NKUS LAB RNS-9703-019; REMOTE NETWORK STATION

Model Number	RNS-9703-019
Medical Device Problem Codes	No Audible Alarm (1019); Protective Measures Problem (3015)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/06/2015
Additional Manufacturer Narrative
The customer reported that the audible alarms spontaneously stops alarming for the remote network station (rns or remote monitoring system).Also, when they checked that sound control, the volume setting is all the way down and will not allow the user to raise it.They stated that the only fix he has found is to unplug the rns power cord and essentially hard restarting the rns.Nihon kohden continues to investigate the reported event.
Event or Problem Description
The customer reported that the audible alarms spontaneously stops alarming for the remote network station (rns or remote monitoring system).Also, when they checked that sound control, the volume setting is all the way down and will not allow the user to raise it.They stated that the only fix he has found is to unplug the rns power cord and essentially hard restarting the rns.
Additional Manufacturer Narrative
The customer reported that the audible alarms spontaneously stops alarming for the remote network station (rns or remote monitoring system).Also, when they checked that sound control, the volume setting is all the way down and will not allow the user to raise it.They stated that the only fix he has found is to unplug the rns power cord and essentially hard restarting the rns.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(s) contain no information (ni), as attempts to obtain information were made, but not provided: a2 - a6.
Event or Problem Description
The customer reported that the audible alarms spontaneously stops alarming for the remote network station (rns or remote monitoring system).Also, when they checked that sound control, the volume setting is all the way down and will not allow the user to raise it.They stated that the only fix he has found is to unplug the rns power cord and essentially hard restarting the rns.
Event or Problem Description
The customer reported that the audible alarms spontaneously stops alarming for the remote network station (rns or remote monitoring system).Also, when they checked that sound control, the volume setting is all the way down and will not allow the user to raise it.They stated that the only fix he has found is to unplug the rns power cord and essentially hard restarting the rns.
Additional Manufacturer Narrative
The customer reported that the audible alarms spontaneously stops alarming for the remote network station (rns or remote monitoring system).Also, when they checked that sound control, the volume setting is all the way down and will not allow the user to raise it.They stated that the only fix he has found is to unplug the rns power cord and essentially hard restarting the rns.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.

• Brand Name: RNS-9703-019
• Common Device Name: REMOTE NETWORK STATION
• Manufacturer (Section D): NKUS LAB; 5 jenner, suite 180; attn.: susan shadley; irvine CA 92618
• MDR Report Key: 5501381
• Report Number: 2032233-2015-00074
• Device Sequence Number: 14352242
• Product Code: MHX
• UDI-Device Identifier: 00851725007009
• UDI-Public: 00851725007009
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/05/2015
• Report Date (Section F): 05/05/2015

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-9703-019
• Device Catalogue Number: RNS-9703-019
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/06/2015
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided; Not provided
• Initial Report FDA Received Date: 03/15/2016
• Supplement Report FDA Received Date: 03/25/2021; 03/25/2021; 03/15/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 05/05/2015