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

Model Number RNS-9703-019

Device Problems No Display/Image (1183); Failure to Power Up (1476)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/26/2015

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer states that the remote network station (rns or remote monitoring system) is not functioning properly.The rns display went black.There were no power leds lit up.The biomedical engineer attempted to troubleshoot the rns and determined that it will not power on.An rns from another department was successfully installed for use.Customer is being shipped an exchange rns.Nihon kohden continues to investigate the reported event.Nihon kohden will submit a supplemental report in accordance with 21 cfr part 803.56 when additional information becomes available.

Event Description

The biomedical engineer states that the remote network station (rns or remote monitoring system) is not functioning properly.The rns display went black.There were no power leds lit up.The biomedical engineer attempted to troubleshoot the rns and determined that it will not power on.An rns from another department was successfully installed for use.Customer is being shipped an exchange rns.

• Brand Name: RNS-9703-019
• Type of Device: REMOTE NETWORK STATION
• Manufacturer (Section D): NKUS LAB; 5 jenner, suite 180; attn: thomas bento; irvine CA 92618
• Manufacturer (Section G): NKUS LAB; 5 jenner, suite 180; attn: thomas bento; irvine CA 92618
• Manufacturer Contact: thomas bento ; 5 jenner, suite 180; irvine, CA 92618 ; 9492687708
• MDR Report Key: 5356524
• MDR Text Key: 35922295
• Report Number: 2032233-2016-00001
• 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: 12/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RNS-9703-019
• Device Catalogue Number: RNS-9703-019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/26/2015
• Date Device Manufactured: 09/18/2013
• 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