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

Model Number	RNS-9703-019
Medical Device Problem Codes	Application Program Problem (2880); Application Program Freezes or Fails to Launch (4031)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The biomedical engineer reported: "this morning at 8am the rns on 4a locked up and was not operational.The rns displayed the sectors, but no waveforms.When the mouse was moved the windows 7 wait circle showed on the screen and would not allow any actions to be taken with either the mouse or keyboard.We were forced to hard reset the monitor to get the central station rns to work again." the war room was unaffected by the rns lockup, and they were able to monitors the patients.The 4a unit is now operational.No patient harm was reported.Additional model information: concomitant medical products: the following device was used in conjunction with the model #: ni, serial #: ni.
Event or Problem Description
The biomedical engineer reported: "this morning at 8am the rns on 4a locked up and was not operational.The rns displayed the sectors, but no waveforms.When the mouse was moved the windows 7 wait circle showed on the screen and would not allow any actions to be taken with either the mouse or keyboard.We were forced to hard reset the monitor to get the central station rns to work again.".

• 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; attn.: susan shadley; irvine, CA 92618 ; 9492687708
• MDR Report Key: 5501970
• Report Number: 2032233-2015-00103
• Device Sequence Number: 3084121
• Product Code: MHX
• UDI-Device Identifier: 00851725007009
• UDI-Public: 00851725007009
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: 04/27/2015
• Supplement Date Received by Manufacturer: 04/27/2015
• 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