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.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 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 the remote network station (rns) was not alarming.When they attempted to reboot the unit, it got stuck in a boot loop.No harm or injury was reported.
Additional Manufacturer Narrative
Details of complaint: the customer reported that the remote network station (rns) was not alarming.When they attempted to reboot the unit, it got stuck in a boot loop.No patient harm was reported.Investigation summary: the root cause of the alarms not working is user error related to settings.The customer turned on a setting that disabled the alarms for certain parameters.The customer was provided education to resolve the issue.The issue of boot looping was resolved after the customer replaced the switch the rns was connected to.As such, the switch likely failed as a result of hardware failure.Hardware failure could come as a result of physical damage, heat damage, or electrical damage.Physical damage could occur due to impacts with objects and other surfaces.Heat damage could occur due to improper maintenance or placement.Electrical damage could occur during a power outage or power surge.Wear and tear due to aging or frequency of use can gradually degrade components.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.The following fields contain no information (ni), as attempts to obtain information were made, but not provided: a2 - a6 b6 b7 d10 attempt #1 10/05/2021 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #2 10/12/2021 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #3 10/19/2021 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Additional information: b4 date of this report g3 date received by manufacturer g6 type of report h2 if follow-up, what type? h6 event problem and evaluation codes h10 additional manufacturer narrative.

• Brand Name: RNS-6803-3464
• 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: 12662124
• Report Number: 8030229-2021-01820
• Device Sequence Number: 4480760
• Product Code: MHX
• UDI-Device Identifier: 00851725007139
• UDI-Public: 00851725007139
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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: User Facility
• Initial Reporter Occupation: Biomedical Engineer
• 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: 09/21/2021
• Supplement Date Received by Manufacturer: 05/26/2023
• Initial Report FDA Received Date: 10/19/2021
• Supplement Report FDA Received Date: 05/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/02/2019
• 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