MAUDE Adverse Event Report: NATUS NEURO INCORPORATED EVD/CSF; EDS 3 DRAINAGE SYSTEM

Model Number 821730

Device Problem Fluid/Blood Leak (1250)

Patient Problem Cerebrospinal Fluid Leakage (1772)

Event Date 05/11/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Complaint notification received from codman.Customer confirms product not available for return.Product was replaced with a functional unit.

Event Description

Liquid does not drain into collection bag.

• Brand Name: EVD/CSF
• Type of Device: EDS 3 DRAINAGE SYSTEM
• Manufacturer (Section D): NATUS NEURO INCORPORATED; 5955 pacific center boulevard; san diego CA 92121
• Manufacturer (Section G): NATUS NEUROLOGY INCORPORATED; 5955 pacific center boulevard; san diego CA 92121
• Manufacturer Contact: janessa boone ; 3150 pleasant view road; middleton, WI 53562 ; 6088298603
• MDR Report Key: 8739252
• MDR Text Key: 149346919
• Report Number: 3010611950-2019-00044
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K061568
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial
• Report Date: 06/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 821730
• Device Catalogue Number: 821730
• Device Lot Number: 178999
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/14/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 17 YR