MAUDE Adverse Event Report: NKUS LAB RNS-6803-7450; 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	09/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported that no sounds are coming from the remote network station (rns) even though the rns was visually showing that it was alarming.No further information was provided except that no harm or injury occured during this event.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 no sounds are coming from the remote network station (rns) even though the rns was visually showing that it was alarming.No further information was provided except that no harm or injury occured during this event.
Additional Manufacturer Narrative
Details of complaint: the customer reported that no sound was coming from the remote network station (rns) even though the rns was visually showing that it was alarming.No further information was provided.No patient harm was reported.Investigation summary: the root cause of alarms not alarming audibly could not be determined as the customer declined nihon kohden technical support (nk ts) attempts to troubleshooting.No further issues were reported by the customer.It is likely that the customer was able to resolve the issue without nk assistance.Possible causes are likely related to audio settings on the rns not having been set correctly.A serial number review of the reported device does not reveal additional related complaints.A complaint history review of the customer's account does not reveal trends for similar complaints.
Event or Problem Description
The customer reported that no sound was coming from the remote network station (rns) even though the rns was visually showing that it was alarming.No harm or injury occured during this event.

• Brand Name: RNS-6803-7450
• Common Device Name: REMOTE NETWORK STATION
• Manufacturer (Section D): NKUS LAB; attn: shama mooman; 14 bunsen; irvine CA 92618
• Manufacturer (Section G): NKUS LAB; attn: shama mooman; 14 bunsen; irvine CA 92618
• Manufacturer Contact: shama mooman ; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama, CA 359-8-580 ; JA 359-8580 ; 9492687488
• MDR Report Key: 12600601
• Report Number: 8030229-2021-01780
• Device Sequence Number: 11618326
• Product Code: MHX
• UDI-Device Identifier: 00851725007153
• UDI-Public: 00851725007153
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K102376
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/30/2023

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2021
• Supplement Date Received by Manufacturer: 05/26/2023
• Initial Report FDA Received Date: 10/08/2021
• Supplement Report FDA Received Date: 05/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/04/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown