MAUDE Adverse Event Report: NKUS LAB RNS-9703-024; REMOTE NETWORK STATION

Model Number	RNS-9703-024
Medical Device Problem Codes	No Display/Image (1183); Display or Visual Feedback Problem (1184)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The biomedical engineer reported that the remote network station (rns) had a blank display after a power outage.The rns was monitoring patients and it is unclear whether there was a central nurse's station (cns) in use as a primary monitoring system when this rns failed.Nihon kohden will exchange the rns to resolve the issue.No patient harm was reported.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.Concomitant medical product: telemetry devices, no model or serial numbers were provided.
Event or Problem Description
The biomedical engineer reported that the remote network station (rns) had a blank display after a power outage.The rns was monitoring patients and it is unclear whether there was a central nurse's station (cns) in use as a primary monitoring system when this rns failed.No patient harm was reported.
Event or Problem Description
The biomedical engineer reported that the remote network station (rns) had a blank display after a power outage.The rns was monitoring patients and it was unclear whether there was a central nurse's station (cns) in use as a primary monitoring system when this rns failed.No patient harm was reported.
Additional Manufacturer Narrative
Details of complaint: the biomedical engineer reported that the remote network station (rns) had a blank display after a power outage.The rns was monitoring patients and it was unclear whether there was a central nurse's station (cns) in use as a primary monitoring system when this rns failed.No patient harm was reported.Service requested / performed: exchange.On (b)(6) 2019 an exchange unit was sent to the customer.On (b)(6) 2019 the reported device was received by nihon kohden (nk); however, no evaluation was performed based on the subsequent information obtained from the customer, see investigation summary below.Investigation summary: the customer later clarified that the rns had a communication loss message.Communication loss flashes to let users know the communication link between the rns and the monitored devices are interrupted.The customer stated the power outage caused the network switches to fail, leading to interruption of the communication link between the rns device and the telemetry units.Network switches are part of the it infrastructure that provides network connectivity to nk devices as well as other hospital systems.Thus, this is not isolated to nk devices.The root cause of the reported event was attributable to environmental factor.The service history for this rns shows this is an isolated incident.No capa is required at this time.The following fields contain no information (ni), as attempts to obtain information were made, but not provided: a2 - a6.Additional device information: d10 concomitant medical device: the following devices were used in conjunction with the rns: telemetry transmitters: model #: ni.Serial #: ni.

• Brand Name: RNS-9703-024
• Common Device Name: REMOTE NETWORK STATION
• Manufacturer (Section D): NKUS LAB; 5 jenner, suite 180; attn: shama mooman; irvine CA 92618
• Manufacturer (Section G): NKUS LAB; 5 jenner, suite 180; attn: shama mooman; irvine CA 92618
• Manufacturer Contact: shama mooman ; 5 jenner, suite 180; irvine, CA 92618 ; 9492687708
• MDR Report Key: 9073681
• Report Number: 2032233-2019-00466
• Device Sequence Number: 11395341
• Product Code: MHX
• UDI-Device Identifier: 00851725007016
• UDI-Public: 00851725007016
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 02/08/2022

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-9703-024
• Device Catalogue Number: RNS-9703-024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2019
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2019
• Supplement Date Received by Manufacturer: 02/07/2022
• Initial Report FDA Received Date: 09/16/2019
• Supplement Report FDA Received Date: 02/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/02/2016
• 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: TELEMETRY TRANSMITTERS; TELEMETRY TRANSMITTERS
• Patient Sex: Unknown