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

Model Number RNS-9703-019

Device Problems Use of Incorrect Control/Treatment Settings (1126); Application Program Problem (2880)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/16/2015

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer (bme) reported that the rns had numerics but no waveforms, no trending data and no full disclosure.They were unable to print.The device was set to local filing.The issues occurred at approximately 0400 hrs.This is a recent install.The device was rebooted and an "ip conflict" error message was observed during shutdown.After rebooting, the rns was functional.Nk ts advised the biomed to monitor for further problems.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 Description

The biomedical engineer (bme) reported that the rns had numerics but no waveforms, no trending data and no full disclosure.They were unable to print.The device was set to local filing.The issues occurred at approximately 0400 hrs.

• Brand Name: RNS-9703-019
• Type of Device: REMOTE NETWORK STATION
• Manufacturer (Section D): NKUS LAB; 5 jenner, suite180; 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: 5501425
• MDR Text Key: 221262475
• Report Number: 2032233-2015-00086
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K023475
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 03/15/2015

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
• 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
• Initial Date Manufacturer Received: 03/15/2015
• Initial Date FDA Received: 03/15/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1