MAUDE Adverse Event Report: NATUS NEURO INCORPORATED EDS-3 COMPLETE (STERILE) WITHOUT VENTRICULAR CATHETER

Model Number	821731C
Medical Device Problem Code	Failure to Disconnect (2541)
Health Effect - Clinical Code	Cerebrospinal Fluid Leakage (1772)
Date of Event	12/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Device from different lot tested.Unable to reproduce failure observed by complaint.
Event or Problem Description
Drainage bag broke off at the luer lock connection site.

• Brand Name: EDS-3 COMPLETE (STERILE) WITHOUT VENTRICULAR CATHETER
• Common Device Name: EDS-3
• Manufacturer (Section D): NATUS NEURO INCORPORATED; 3150 pleasant view road; middleton WI 53562
• MDR Report Key: 8241534
• Report Number: 3010611950-2018-00003
• Device Sequence Number: 19310896
• Product Code: JXG
• UDI-Device Identifier: 10886704040958
• UDI-Public: 10886704040958
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K162437
• 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): 12/12/2018

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 Expiration Date: 06/30/2021
• Device Model Number: 821731C
• Device Catalogue Number: 821731C
• Device Lot Number: 206224
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/12/2018
• Initial Report FDA Received Date: 01/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other