MAUDE Adverse Event Report: NKUS LAB RNS-9703-024; REMOTE NETWORK STATION

Model Number	RNS-9703-024
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Intermittent Loss of Power (4016)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The biomedical engineer (bme) reported that the rns kept power cycling.This is a sign of network connectivity issues.Resetting the rns server resolved the issue.No patient harm 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 biomedical engineer (bme) reported that the rns kept power cycling.

• Brand Name: RNS-9703-024
• Common Device Name: REMOTE NETWORK STATION
• Manufacturer (Section D): NKUS LAB; 5 jenner, suite 180; attn.: susan shadley; irvine CA 92618
• Manufacturer (Section G): NKUS LAB; 5 jenner, suite 180; attn.: susan shadley; irvine CA 92618
• Manufacturer Contact: susan shadley ; 5 jenner, suite 180; attn.: susan shadley; irvine, CA 92618 ; 9492687708
• MDR Report Key: 5501508
• Report Number: 2032233-2015-00116
• Device Sequence Number: 703262
• Product Code: MHX
• UDI-Device Identifier: 00851725007016
• UDI-Public: 00851725007016
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K023475
• 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): 06/15/2016

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-9703-024
• Device Catalogue Number: RNS-9703-024
• 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: 05/08/2015
• Supplement Date Received by Manufacturer: 05/08/2015
• Initial Report FDA Received Date: 03/15/2016
• Supplement Report FDA Received Date: 03/15/2016
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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