MAUDE Adverse Event Report: NKUS LAB RNS-6803-7450; REMOTE NETWORK STATION

Model Number	RNS-6803-7450
Medical Device Problem Codes	Device Alarm System (1012); No Audible Alarm (1019); Protective Measures Problem (3015)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The biomedical engineer reported that the remote network system (rns), the secondary monitoring system, did not provide audio.There was no sound for the alarms, qrs sync sounds, etc.The issue was resolved by rebooting the unit.Customer was unwilling to gather logs.No patient harm 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.Concomitant medical device fields contain no information (ni), as attempts to obtain information were made, but not provided.
Event or Problem Description
The biomedical engineer reported that the remote network system (rns), the secondary monitoring system, did not provide audio.There was no sound for the alarms, qrs sync sounds, etc.The issue was resolved by rebooting the unit.Customer was unwilling to gather logs.No patient harm reported.
Event or Problem Description
The biomedical engineer reported that the remote network system (rns), the secondary monitoring system, did not provide audio.There was no sound for the alarms, qrs sync sounds, etc.The issue was resolved by rebooting the unit.Customer was unwilling to gather logs.No patient harm reported.
Additional Manufacturer Narrative
Details of complaint: on (b)(6) 2019 the customer at (b)(6) hospital reported that the rns (remote nursing station) model a/rns-6803, sn:(b)(6) lost audio.The rns was monitoring patients but was not producing an audible sound.The nk tech support specialist had the customer reboot the rns, which resolved the issue.The customer was not willing to provide log files and more information.Service requested / performed: troubleshooting.Investigation summary: the root cause of the issue is halted audio services because of a possible bug in the windows operating system.A new software 02-10a is released to resolve this audio issue.The risk priority number is determined to be low.

• Brand Name: RNS-6803-7450
• Common Device Name: REMOTE NETWORK STATION
• Manufacturer (Section D): NKUS LAB; 14 bunsen; attn: shama mooman; irvine CA 92618
• MDR Report Key: 9263308
• Report Number: 2032233-2019-00611
• Device Sequence Number: 17127290
• Product Code: MHX
• UDI-Device Identifier: 00851725007153
• UDI-Public: 00851725007153
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K102376
• 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): 11/11/2020

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-6803-7450
• Device Catalogue Number: RNS-6803-7450
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/07/2019
• Supplement Date Received by Manufacturer: 08/30/2020
• Initial Report FDA Received Date: 10/31/2019
• Supplement Report FDA Received Date: 11/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1