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

Model Number EDNS-9001

Device Problems Overheating of Device (1437); Device Inoperable (1663); Device Issue (2379)

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

Event Date 01/11/2018

Event Type  malfunction  

Manufacturer Narrative

The customer reported that the prefense monitor was overheating and shut down due to a bad cpu fan.They were provided with the part number for a whole unit replacement, since individual parts are not available for this model.No patient harm was reported.

Event Description

The customer reported that the prefense monitor was overheating and shut down due to a bad cpu fan.

Event Description

The customer reported that the prefense monitor was overheating and shut down due to a bad cpu fan.

Manufacturer Narrative

H10: additional narrative: the customer reported that the cpu fan is bad and causing the system to overheat and shutdown.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 16/18/2011, which is 6 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.A review of device history found no previously similar reported issues with the unit or nka servicing.No similar tickets using term "heatsink fan bad" were found.The root cause of the heatsink fan going bad was unable to determine.The possible cause of the issue was determined to be dust accumulation on the heatsink fan.The device was in use with a patient and there was no reported patient harm.Correction: f9.Approximate age of device: date added.G4.Date received by manufacturer: should be 01/11/2018 not 02/07/2018 as listed on mdr initial report.Additional information: b4.Date of this report.D4.Unique identifier (udi) number.E2.Health professional.E3.Occupation.F7.Type of report.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.

• 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: 7249636
• MDR Text Key: 99798211
• Report Number: 2032233-2018-00038
• 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: 02/07/2018
• 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