MAUDE Adverse Event Report: NKUS LAB CENTRAL MONITORING SYSTEM; CENTRAL MONITORING STATION

Model Number	EDNS-9001
Medical Device Problem Codes	Application Program Problem (2880); Unintended Application Program Shut Down (4032)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The biomedical engineer (bme) reported that the prefense system was shutting down.They were able to get the device back on last night, but they have noticed that the power light is flashing, and the unit is not displaying content.Tech support (ts) informed them that this was an end of life device.The customer later told tech support stated that they will be replacing the motherboard on this device.This was not in patient use.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.
Event or Problem Description
The biomedical engineer (bme) reported that the prefense system was shutting down.They were able to get the device back on last night, but they have noticed that the power light is flashing, and the unit is not displaying content.Tech support (ts) informed them that this was an end of life device.The customer later told tech support stated that they will be replacing the motherboard on this device.This was not in patient use.
Event or Problem Description
The biomedical engineer (bme) reported that the prefense system was shutting down on its own.They were able to get the device back up and running, but noticed that the power light was flashing, and the unit was not displaying content.Tech support (ts) informed them that this was an end of life device.This was not in patient use.
Additional Manufacturer Narrative
Details of complaint: the biomedical engineer (bme) reported that the prefense system was shutting down on its own.They were able to get the device back up and running, but noticed that the power light was flashing, and the unit was not displaying content.Tech support (ts) informed them that this was an end-of-life device.No patient harm or injury was reported.Investigation summary: ts informed the customer that the device was no longer supported as it is in end of life and could no longer be sent in for repair.The device had been in service since (b)(6) 2012.A review of the history of the serial number identified no similar events.Based on the available information, a definitive root cause could not be identified.Since the device was already in end of life/service, it is possible that the internal hardware (i.E.Power supply, hdd) of the device may have failed due to wear and tear and had caused the issue.The issue is regarding a product that is already in end of life/service.Additional information: 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: CENTRAL MONITORING SYSTEM
• Common Device Name: CENTRAL MONITORING STATION
• Manufacturer (Section D): NKUS LAB; attn: shama mooman; 14 bunsen; irvine CA 92618
• Manufacturer (Section G): NKUS LAB; 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: 13198586
• Report Number: 2032233-2022-02329
• Device Sequence Number: 6046264
• Product Code: DRG
• UDI-Device Identifier: 00851725007023
• UDI-Public: 00851725007023
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K102106
• 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): 04/06/2023

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: EDNS-9001
• Device Catalogue Number: EDNS-9001
• 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: 12/08/2021
• Supplement Date Received by Manufacturer: 03/02/2023
• Initial Report FDA Received Date: 01/07/2022
• Supplement Report FDA Received Date: 04/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/10/2011
• 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
• Patient Sex: Unknown