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

Model Number	RNS-9703-242
Medical Device Problem Code	Protective Measures Problem (3015)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	08/13/2021
Type of Reportable Event	Death
Additional Manufacturer Narrative
The customer reported that upon reviewing a patients data who has just recently passed away they determined that the incorrect time was noted on all of the information when viewed from the remote network station (rns).They also stated that they were able to physically view the event of when the patient passed away on this rns, despite it happening earlier in the day.The event did alarm on the bedside monitor (bsm) and the departments main central nurse's station (cns).The rns also alarmed, but due to it being on the incorrect time, the alarm was delayed.The customer confirmed that the patient death was anticipated and not due to the rns malfunction.The following fields contain no information (ni), as attempts to obtain information were made, but not provided: attempt #: on (b)(6) 2021 emailed customer via (b)(6) for all items under the no information section.An "unknown" reply was received.The following devices were used in conjunction with the rns, but did not experience a failure: bsm - model: ni, s/n: ni, approximate age of the device: ni, device manufacturer date: ni, unique identifier (udi) #: ni.Cns - model: ni, s/n: ni, approximate age of the device: ni, device manufacturer date: ni, unique identifier (udi) #: ni.
Event or Problem Description
The customer reported that upon reviewing a patients data who has just recently passed away they determined that the incorrect time was noted on all of the information when viewed from the remote network station (rns).They also stated that they were able to physically view the event of when the patient passed away on this rns, despite it happening earlier in the day.The event did alarm on the bedside monitor (bsm) and the departments main central nurse's station (cns).The rns also alarmed, but due to it being on the incorrect time, the alarm was delayed.The customer confirmed that the patient death was anticipated and not due to the rns malfunction.

• 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: 12434003
• Report Number: 2080783-2021-01640
• Device Sequence Number: 19670545
• Product Code: MHX
• UDI-Device Identifier: 00851725007122
• UDI-Public: 00851725007122
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 09/07/2021
• Report Date (Section F): 09/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 08/13/2021
• Device Age: 36 MO
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/07/2021
• 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: BEDSIDE MONITOR (BSM); CENTRAL NURSE'S STATION (CNS)
• Outcome Attributed to Adverse Event: Death
• Date Report Sent to FDA: 09/07/2021