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

Model Number EDNS-9001

Device Problems Display or Visual Feedback Problem (1184); Failure to Power Up (1476)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/14/2021

Event Type  malfunction  

Manufacturer Narrative

Nihon kohden technician advised the customer that this product line is no longer supported and has reached its end-of-life expectancy.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 Description

The customer reported that the prefense monitor's display was blue and displayed a message that the unit will shut down in order to not damage the unit and when the customer attempted to power it back on, the unit would not power on.No patient harm was reported.Nihon kohden technician advised the customer that this product line is no longer supported and has reached its end of life expectancy.

Manufacturer Narrative

Details of complaint: the customer reported that the prefense monitor's display was blue and displayed a message that stated, the unit will shut down in order to not damage the unit.When the customer attempted to power it back on, the unit would not power on.Nihon kohden technical support (nk ts) advised the customer that this product line is no longer supported and has reached its end-of-life.No patient harm or injury was reported.Investigation summary: nk ts informed the customer that the product was no longer supported as it is in end of life and could no longer be sent in for repair.On a follow-up, the customer indicated that they had removed the device from service.The device had been in service since 03/01/2016.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 is 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.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.

Event Description

The customer reported that the prefense monitor's display was blue and displayed a message that stated, the unit will shut down in order to not damage the unit.When the customer attempted to power it back on, the unit would not power on.No patient harm was reported.

• Brand Name: CENTRAL MONITORING SYSTEM
• Type of Device: 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 ; safety mgmt dept, quality mgmt; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama, CA 359-8-580 ; JA 359-8580 ; 9492687488
• MDR Report Key: 12443803
• MDR Text Key: 282229207
• Report Number: 8030229-2021-01643
• Device Sequence Number: 1
• Product Code: DRG
• UDI-Device Identifier: 00851725007023
• UDI-Public: 00851725007023
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102106
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 03/21/2023

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
• Device Operator: 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
• Initial Date Manufacturer Received: 08/14/2021
• Initial Date FDA Received: 09/08/2021
• Supplement Dates Manufacturer Received: 03/02/2023
• Supplement Dates FDA Received: 03/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/04/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1