MAUDE Adverse Event Report: NIHON KOHDEN DIGITAL HEALTH SOLUTIONS INC. RNS-6803-7460; REMOTE NETWORK STATION

Model Number	RNS-6803-7460
Medical Device Problem Codes	No Audible Alarm (1019); Protective Measures Problem (3015); Audible Prompt/Feedback Problem (4020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/19/2022
Type of Reportable Event	Death
Event or Problem Description
The customer reported that this remote nurse's station (rns) did not alarm; however, the central nurse's station (cns) did alarm.This caused a delay in treatment and the patient passed away.
Additional Manufacturer Narrative
The customer reported that this remote nurse's station (rns) did not alarm; however, the central nurse's station (cns) did alarm.According to the customer, they didn't hear an alarm from the rns when the patient was alarming; however, they did hear it at the cns and in the room.This caused a delay in treatment and the patient passed away.Technical support (ts) sent the customer the investigation guide and the steps to pull the log files.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 following fields contain no information (ni), as attempts to obtain information were made, but not provided: patient information: attempt # 1: 06/28/2022 a phone call was made in an attempt to gather patient and device information, a voice mail was left for (b)(6) to call me back with the patient and device information.Attempt # 2: 07/01/2022 a phone call was made in an attempt to gather patient and device information, a voice mail was left for (b)(6) to call me back with the patient and device information.Attempt # 3 07/08/2022 a phone call was made in an attempt to gather patient and device information, a voice mail was left for (b)(6) to call me back with the patient and device information.The following fields are not available (n/a) to this report: patient date of death.Additional model information: concomitant medical device: the following device was used in conjunction with the rns: cns: model #: ni, serial #: ni, device manufacturer data: ni, unique identifier (udi) #: ni, returned to nihon kohden: ni.
Event or Problem Description
The customer reported that this remote nurse's station (rns) did not alarm, causing a delay in patient treatment and the patient passed away.However, the central nurse's station (cns) did alarm.
Additional Manufacturer Narrative
Details of complaint: the customer reported that this remote nurse's station (rns) did not alarm, causing a delay in patient treatment and the patient passed away.However, the central nurse's station (cns) did alarm.Details of complaint: the root cause of alarms not alarming is related to use of defective software.Version 02-10 for the rns has known alarm audio issues, which was resolved in version 02-10a.The customer was using 02-10.Nka personnel were sent on-site to perform software upgrades for the facility's rns systems.A serial number review of the reported device does not reveal additional related complaints.The alarm issues with the rns version 2-10 have been resolved with newer software updates.The following fields contain no information (ni), as attempts to obtain information were made, but not provided: a2 - a6 b6 b7 d10 attempt # 1: (b)(6) 2022 a phone call was made in an attempt to gather patient and device information, a voice mail was left for (b)(6) to call me back with the patient and device information.Attempt # 2: (b)(6) 2022 a phone call was made in an attempt to gather patient and device information, a voice mail was left for (b)(6) to call me back with the patient and device information.Attempt # 3 (b)(6) 2022 a phone call was made in an attempt to gather patient and device information, a voice mail was left for (b)(6) to call me back with the patient and device information.Additional model information: d10 concomitant medical device: the following device was used in conjunction with the rns: cns: model #: ni serial #: (b)(6) device manufacturer data: ni unique identifier (udi) #: (b)(4).Additional information: b2 date of death b4 date of this report g3 date received by manufacturer g6 type of report h2 if follow-up, what type? h6 event problem and evaluation codes h10 additional manufacturer narrative.

• Brand Name: RNS-6803-7460
• Common Device Name: REMOTE NETWORK STATION
• Manufacturer (Section D): NIHON KOHDEN DIGITAL HEALTH SOLUTIONS INC.; attn: shama mooman; 14 bunsen; irvine CA 92618
• Manufacturer (Section G): NIHON KOHDEN DIGITAL HEALTH SOLUTIONS INC.; attn: shama mooman; 14 bunsen; irvine CA 92618
• Manufacturer Contact: shama mooman ; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama, CA 359-8-580 ; JA 359-8580 ; 9492687488
• MDR Report Key: 15048674
• Report Number: 2032233-2022-02966
• Device Sequence Number: 14645750
• Product Code: MHX
• UDI-Device Identifier: 00851725007184
• UDI-Public: 00851725007184
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): 06/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: RNS-6803-7460
• Device Catalogue Number: RNS-6803-7460
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2022
• Supplement Date Received by Manufacturer: 05/26/2023
• Initial Report FDA Received Date: 07/18/2022
• Supplement Report FDA Received Date: 06/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/28/2020
• 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: CNS; CNS
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown