MAUDE Adverse Event Report: NATUS NEURO INCORPORATED CODMAN EXTERNAL DRAINAGE SYSTEM III; SHUNT, CENTRAL NERVOUS SYSTEM & COMPS

Model Number	821730
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/05/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reference (b)(4).Product discarded onsite, so unable to return for further investigation, therefore no root cause could be determined.
Event or Problem Description
Disconnection of male termination with system was fractured, causing drainage system to become disconnected at the ventricular catheter from the tubing.

• Brand Name: CODMAN EXTERNAL DRAINAGE SYSTEM III
• Common Device Name: SHUNT, CENTRAL NERVOUS SYSTEM & COMPS
• Manufacturer (Section D): NATUS NEURO INCORPORATED; 3150 pleasant view road; middleton WI 53562
• MDR Report Key: 8345394
• Report Number: 3010611950-2019-00006
• Device Sequence Number: 1915859
• Product Code: JXG
• UDI-Device Identifier: 10886704040910
• UDI-Public: 10886704040910
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K954021
• 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): 01/15/2019

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: 821730
• Device Catalogue Number: 821730
• Device Lot Number: 175517
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/15/2019
• Initial Report FDA Received Date: 02/15/2019
• 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