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

Model Number EDNS-9001

Device Problem No Display/Image (1183)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/17/2018

Event Type  malfunction  

Manufacturer Narrative

The customer reported that: "during normal operation, the device will got into a blue screen with errors.After the crash, the customer performed a hard restart the device and the device will come back up for about two hours and crash again".No consequence or impact to the patient was reported.Nihon kohden continues to investigate the reported event and will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

Event Description

The customer reported that: "during normal operation, the device will got into a blue screen with errors.After the crash, the customer performed a hard restart the device and the device will come back up for about two hours and crash again".No consequence or impact to the patient.

Event Description

The customer reported that: "during normal operation, the device will got into a blue screen with errors.After the crash, the customer performed a hard restart the device and the device will come back up for about two hours and crash again".No consequence or impact to the patient.

Manufacturer Narrative

Complaint details: the customer reported on 12/17/2018 that their device keeps crashing.The device goes into blue screen with errors during normal operation.The issue resolved after hard restart of the device but recurs after two hours.Service requested: troubleshooting service provided: troubleshooting investigation result: the a/edns-9001; sn:(b)(4) was placed into service on (b)(6) 2013, which is 5 years at the time of the reported issue.A review of device history found the following issues reported with this unit: 300071130- the unit is not making any sounds; root cause: user error 300153105- the unit is making a grinding noise from fan; root cause: unknown similar tickets using "a/edns-9001 device crash" and "a/edns-9001 crashed" gave no result.Similar tickets using "a/edns-9001 crashes" gave the following result: 19982- prefense crashes; root cause: unknown based on the device service history and similar search query, no adverse trend is suspected with the device.A/edns-9001 service manual revision i provides guidance for troubleshooting, servicing, maintaining or repairing the prefense edns-9001.The root cause of the issue was unable to be determined as the customer was unresponsive so sufficient information could not be obtained, and the device was not sent for evaluation.Corrected information: f9.Approximate age of device: incorrectly calculated.

• Brand Name: CENTRAL MONITORING SYSTEM
• Type of Device: CENTRAL MONITORING STATION
• Manufacturer (Section D): NKUS LAB; 5 jenner, suite 180; attn: shama mooman; irvine CA 92618
• MDR Report Key: 8254834
• MDR Text Key: 133863961
• Report Number: 2032233-2019-00027
• Device Sequence Number: 1
• Product Code: DRG
• Combination Product (y/n): N
• PMA/PMN Number: K102106
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 11/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2019
• 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
• Device Lot Number: NOT APPLICABLE
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/06/2019
• Distributor Facility Aware Date: 10/29/2019
• Device Age: 62 MO
• Event Location: Hospital
• Date Report to Manufacturer: 11/06/2019
• Date Manufacturer Received: 10/29/2019
• Removal/Correction Number: NOT APPLICABLE
• Patient Sequence Number: 1
• Treatment: NOT APPLICABLE.