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
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
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.

• Brand Name: RNS-9703-242
• Common Device Name: REMOTE NETWORK STATION
• Manufacturer (Section D): NKUS LAB; attn: shama mooman; 14 bunsen; irvine CA 92618
• MDR Report Key: 12723763
• Report Number: 2080783-2021-01881
• Device Sequence Number: 3983495
• Product Code: MHX
• UDI-Device Identifier: 00851725007122
• UDI-Public: 00851725007122
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 10/29/2021
• Report Date (Section F): 10/29/2021

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-9703-242
• Device Catalogue Number: RNS-9703-242
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/05/2021
• Device Age: 42 MO
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CENTRAL NURSES STATION (CNS); MULTIPLE TRANSMITTERS
• Date Report Sent to FDA: 10/29/2021