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

Model Number	EDNS-9001
Medical Device Problem Code	Temperature Problem (3022)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/12/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reports that the monitor/screen for the prefense started to smoke.Customer shut the unit down and disconnected the monitor from the main unit.No patient harm was reported.One patient was being monitored on the device, additionally; they were also monitored on two other nihon kohden devices.The unit is being returned for evaluation and repair.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 customer reports that the monitor/screen for the prefense started to smoke.Customer shut the unit down and disconnected the monitor from the main unit.No patient harm was reported.One patient was being monitored on the device, additionally; they were also monitored on two other nihon kohden devices.
Additional Manufacturer Narrative
The customer reported that the monitor/screen for the prefense started to smoke.The customer shut the unit down and disconnected the monitor from the main unit.No patient harm was reported.One patient was being monitored on the device and was also monitored on two other nihon kohden devices.The unit was returned for evaluation and repair, however it was later determined that the monitor/screen was not manufactured by nihon kohden, therefore no evaluation or repair was performed on the unit.Nihon kohden continues to investigate the reported event.Nihon kohden will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

• Brand Name: CENTRAL MONITORING SYSTEM
• Common Device Name: CENTRAL MONITORING STATION
• Manufacturer (Section D): NKUS LAB; 14 brunsen; attn: shama mooman; irvine CA 92618
• MDR Report Key: 6244711
• Report Number: 2032233-2017-00002
• Device Sequence Number: 19081208
• Product Code: DRG
• UDI-Device Identifier: 00851725007023
• UDI-Public: 00851725007023
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2016

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
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/12/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/11/2017
• Supplement Report FDA Received Date: 03/23/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1