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	10/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported that the speakers failed on the remote network system (rns), the secondary monitoring system.They spontaneously stopped working and were making buzzing and humming sounds.The unit was rebooted, but the issue persists.The primary monitoring system, the central nurse's station (cns) was functional and monitoring the same patients when the rns failed.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.The bedside monitors and telemetry transmitters were being monitored on the rns and cns, and the cns information has been provided as well.Central nurse's station, model: cns-6201a, s/n: (b)(4).Bedside monitor, model: bsm-6301a, s/n: (b)(4).Bedside monitor, model: bsm-6301a, s/n: (b)(4).Transmitter, model: gz-130pa, s/n: (b)(4).Transmitter, model: gz-130pa, s/n: (b)(4).
Event or Problem Description
The customer reported that the speakers failed on the remote network system (rns), the secondary monitoring system.They spontaneously stopped working and were making buzzing and humming sounds.The unit was rebooted, but the issue persists.The primary monitoring system, the central nurse's station (cns) was functional and monitoring the same patients when the rns failed.No patient harm reported.
Event or Problem Description
The customer reported that the speakers failed on the remote network system (rns), the secondary monitoring system.They spontaneously stopped working and were making buzzing and humming sounds.The unit was rebooted, but the issue persisted.The primary monitoring system, the central nurse's station (cns) was functional and monitoring the same patients when the rns failed.No patient harm was reported.
Additional Manufacturer Narrative
Details of complaint: the customer reported that the speakers failed on the remote network system (rns), the secondary monitoring system.They spontaneously stopped working and were making buzzing and humming sounds.The unit was rebooted, but the issue persisted.The primary monitoring system, the central nurse's station (cns) was functional and monitoring the same patients when the rns failed.No patient harm was reported.Service requested / performed: exchange.The reported device was returned to nihon kohden (nk) on 12/11/2019.No record of an evaluation was documented as the customer was provided with an exchanged unit.Investigation summary: per hha-21-002, the cause of the reported audio issue is the microsoft audio driver.This issue is mitigated via a software update version 02-10b, whereby the audio driver is reset after each alarm.This software update prevents user/operator from completely silencing the alarm.There have been no reports of audio issues with version 02-10b.Per hha-21-002, in order for use of, or exposure to, the product to cause an adverse health consequence to occur, the following unlikely sequence of events (serial faults) would all need to occur: 1.Critically ill patient is being monitored by an affected device, and the operator changes the volume of the alarm as described previously.2.Alarm volume is reduced by the operator to such a degree that it is less audible.3.Patient undergoes deterioration, and operator fails to notice visual and audible alarm signals.4.Alarms at bedside monitor are not noticed.Although such a sequence of events could occur, it has not been reported and is considered to be unlikely to occur.Further action is not warranted at this time.Additional device information: d10 concomitant medical device: the following device(s) were used in conjunction with the cns: central nurse's station: model #: cns-6201a serial #: (b)(6).Bedside monitor: model #: bsm-6301a serial #: (b)(6).Transmitter: model #: gz-130pa serial #: (b)(6).Additional information: b4 date of this report.D9 device available for evaluation? g3 date received by manufacturer.G6 type of report.H2 if follow-up, what type? h3 device evaluated by manufacturer? h6 event problem and evaluation codes.H10 additional manufacturer narrative.

• Brand Name: RNS-6803-7450
• Common Device Name: REMOTE NETWORK STATION
• Manufacturer (Section D): NKUS LAB; 14 bunsen; attn: shama mooman; irvine CA 92618
• Manufacturer (Section G): NKUS LAB; 14 bunsen; attn: shama mooman; irvine CA 92618
• Manufacturer Contact: shama mooman ; 14 bunsen; irvine, CA 92618 ; 9492687488
• MDR Report Key: 9253153
• Report Number: 2032233-2019-00587
• Device Sequence Number: 1864293
• Product Code: MHX
• UDI-Device Identifier: 00851725007153
• UDI-Public: 00851725007153
• Combination Product (Y/N): N
• Initial Reporter State: DE
• 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): 02/07/2022

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2019
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2019
• Supplement Date Received by Manufacturer: 02/04/2022
• Initial Report FDA Received Date: 10/29/2019
• Supplement Report FDA Received Date: 02/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/10/2018
• 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
• Concomitant Medical Products and Therapy/Usage Dates: BSM-6301A SN (B)(6).; BSM-6301A SN (B)(6).; BSM-6301A SN (B)(6).; BSM-6301A SN (B)(6).; CNS-6801A SN (B)(6).; CNS-6801A SN (B)(6).; GZ-130PA SN (B)(6).; GZ-130PA SN (B)(6).; GZ-130PA SN (B)(6).; GZ-130PA SN (B)(6).
• Patient Sex: Unknown