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

Model Number EDNS-9001

Device Problems No Display/Image (1183); Device Issue (2379)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/19/2018

Event Type  malfunction  

Manufacturer Narrative

The customer reported that the prefense monitor's screen went blank and emitted no sound.They were provided with the part number for a new lcd display to resolve the issue.No patient harm was reported.

Event Description

The customer reported that the prefense monitor's screen went blank and emitted no sound.

Manufacturer Narrative

H10: additional narrative: the customer reported that their monitor goes blank with no sound.Service requested: the customer requested an exchange for the defective unit.Service provided: the customer was provided with part number for the defective unit.Investigation result: the prefense (a/edns-9001; sn: (b)(6) was placed into service on 10/31/2011, which is 7 years prior to the reported issue.A/edns-9001 service manual revision i provides guidance for troubleshooting, servicing, maintaining or repairing the prefense edns-9001.The service manual involves troubleshooting of the display and advises customer on proper action to take.Previously reported issues with this unit indicates that the user error/environmental factor was prevalent with this customer.The root cause of the monitor going blank was unable to determine.The cause of the issue was determined to be failure of the display unit.The device was in use with a patient and there was no reported patient harm.Corrected information: g4.Date received by manufacturer: should be 01/19/2018 not 02/16/2018 as listed on mdr initial report.Additional information: b4.Date of this report.D4.Unique identifier (udi) number: pre-udi requirement.E1.Name and address.E2.Health professional.E3.Occupation.F3-5.Contact for user facility/importer.F6.Date user facility/importer became aware of the event.F7.Type of report.F9.Approximate age of device f11.Date report sent to fda f12.Location where event occurred f13.Date report sent to manufacturer g4.Date received by manufacturer g7.Type of report h2.If follow-up, what type? additional information.Correction.H3.Device evaluated by manufacturer? h6.Event problem and evaluation codes.H10.Additional manufacturer narrative.

Event Description

The customer reported that the prefense monitor's screen went blank and emitted no sound.

• 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: 7277947
• MDR Text Key: 100522791
• Report Number: 2032233-2018-00045
• 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: user facility
• Type of Report: Initial,Followup
• Report Date: 07/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2018
• 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: 07/24/2019
• Distributor Facility Aware Date: 07/24/2019
• Device Age: 81 MO
• Date Report to Manufacturer: 07/24/2019
• Date Manufacturer Received: 07/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NOT APPLICABLE
• Patient Sequence Number: 1