MAUDE Adverse Event Report: NATUS NEURO INCORPORATED NICOLET EDX; EDX BASE UNIT

Model Number	515-015300
Medical Device Problem Code	Smoking (1585)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reference (b)(4).Product returned to natus, determined root cause to be failed dc to dc endicott converter.
Event or Problem Description
Edx base started to smoke heavily.

• Brand Name: NICOLET EDX
• Common Device Name: EDX BASE UNIT
• Manufacturer (Section D): NATUS NEURO INCORPORATED; 3150 pleasant view road; middleton WI 53562
• MDR Report Key: 8499958
• Report Number: 3010611950-2019-00019
• Device Sequence Number: 1432437
• Product Code: GWF
• UDI-Device Identifier: 00382830037433
• UDI-Public: 00382830037433
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K112052
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 515-015300
• Device Catalogue Number: 515-015300
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/20/2019
• Initial Report FDA Received Date: 04/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other