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

Model Number	RNS-6803-7450
Medical Device Problem Code	Protective Measures Problem (3015)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported that their remote network station (rns) is not alarming.They also reported that when they attempted to reboot the unit it got stuck in a boot loop.No harm or injury was reported.
Event or Problem Description
The customer reported that their remote network station (rns) is not alarming.They also reported that when they attempted to reboot the unit it got stuck in a boot loop.No harm or injury was reported.

• Brand Name: RNS-6803-3464
• Common Device Name: REMOTE NETWORK STATION
• Manufacturer (Section D): NKUS LAB; attn: shama mooman; 14 bunsen; irvine CA 92618
• MDR Report Key: 12662123
• Report Number: 2080783-2021-01820
• Device Sequence Number: 20012099
• Product Code: MHX
• UDI-Device Identifier: 00851725007139
• UDI-Public: 00851725007139
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 10/19/2021
• Report Date (Section F): 10/19/2021

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
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/21/2021
• Device Age: 26 MO
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/19/2021
• 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: 10/19/2021