MAUDE Adverse Event Report: NKUS LAB RNS-9703-019; REMOTE NETWORK STATION

Model Number	RNS-9703-019
Medical Device Problem Codes	No Display/Image (1183); Output Problem (3005)
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 customer reported that the screen on the rns was white.Power cycling the unit did not resolve the issue.They were provided with an exchange.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 customer reported that the screen on the rns was white.

• Brand Name: RNS-9703-019
• 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; irvine, CA 92618 ; 9492687708
• MDR Report Key: 5501515
• Report Number: 2032233-2015-00117
• Device Sequence Number: 16763685
• Product Code: MHX
• UDI-Device Identifier: 00851725007009
• UDI-Public: 00851725007009
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 03/15/2016

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-9703-019
• Device Catalogue Number: RNS-9703-019
• 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