MAUDE Adverse Event Report: NKUS LAB RNS-9703-242; REMOTE NETWORK STATION

Model Number	RNS-9703-242
Medical Device Problem Codes	Application Program Problem (2880); Unintended Application Program Shut Down (4032)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported that a memory error constantly popped up on the remote network system (rns) screen.Initially it was reported that when ok was selected, the device would shut down and restart by itself.Later, it was reported that the error message appeared in the middle of the screen, a black box maybe 3 x 4 inches.Pressing ok or in that screen area had no affect and the unit would have to be manually shut down for it to go away.The rns was monitoring patients and there was no central nurse's station (cns) in use as a primary monitoring system when this rns failed.The rns was exchanged to resolve the issue.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 the product is returned for evaluation or new information is obtained.Concomitant medical device information was requested.Nihon kohden was advised that patients were being monitored on the bedside monitors, but no model or serial numbers provided.
Event or Problem Description
The customer reported that a memory error constantly popped up on the remote network system (rns) screen.Initially it was reported that when ok was selected, the device would shut down and restart by itself.Later, it was reported that the error message appeared in the middle of the screen, a black box maybe 3 x 4 inches.Pressing ok or in that screen area had no affect and the unit would have to be manually shut down for it to go away.The rns was monitoring patients and there was no 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: on (b)(6) 2019 the customer reported that rns ((b)(4), sn: (b)(6)) constantly displayed a "memory error" message on the screen.When the "ok" button was pressed, the device would shut down and restart on its own.This failure was also reported on 2 other rns devices on 2 other tickets ((b)(4) & (b)(4)).Nka repair center evaluated the device sent in on ticket (b)(4), serial # (b)(6).The reported incident could not be duplicated.No issues were observed.This device with sn: (b)(6) was put into service on (b)(6) 2019.The service history shows this is an isolated incident.Service requested / performed: troubleshooting.Investigation summary: the root cause of this issue cannot be determined.Since the root cause was unable to be determined, no capa is required.Without a root cause, the counter measure to prevent recurrence cannot be performed.The overall risk of this event is determined to be "medium." the following fields are not applicable (na) to the mdr report: b2.B6.B7.D4 lot # & expiration date.D6a & d6b.D7b.F1 - f14.G4 device bla number.G5.G7.H7.H9.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 device(s) were used in conjunction with the rns: bsm:.Model #: ni.Serial #: ni.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.
Event or Problem Description
The customer reported that a memory error constantly popped up on the remote network system (rns) screen.Initially it was reported that when ok was selected, the device would shut down and restart by itself.Later, it was reported that the error message appeared in the middle of the screen, a black box maybe 3 x 4 inches.Pressing ok or in that screen area had no affect and the unit would have to be manually shut down for it to go away.The rns was monitoring patients and there was no central nurse's station (cns) in use as a primary monitoring system when this rns failed.No patient harm was reported.

• Brand Name: RNS-9703-242
• Common Device Name: REMOTE NETWORK STATION
• Manufacturer (Section D): NKUS LAB; attn: shama mooman; 5 jenner, suite 180; irvine CA 92618
• MDR Report Key: 8984415
• Report Number: 2032233-2019-00447
• Device Sequence Number: 19664110
• Product Code: MHX
• UDI-Device Identifier: 00851725007122
• UDI-Public: 00851725007122
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 08/05/2021

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-9703-242
• Device Catalogue Number: RNS-9703-242
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2020
• Initial Date Received by Manufacturer: 08/16/2019
• Supplement Date Received by Manufacturer: 07/08/2021
• Initial Report FDA Received Date: 09/10/2019
• Supplement Report FDA Received Date: 08/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BEDSIDE MONITOR; BEDSIDE MONITOR