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

Model Number 821731C

Device Problems Disconnection (1171); Fluid/Blood Leak (1250)

Patient Problem Cerebrospinal Fluid Leakage (1772)

Event Date 09/10/2019

Event Type  malfunction  

Manufacturer Narrative

Reference (b)(4).Complaint received from codman.Natus to report based on knowledge of the event.

Event Description

Eds3 unit has leakage at distal connection to catheter.

• Brand Name: EVD/CSF
• Type of Device: EDS-3 COMPLETE (STERILE) WITHOUT VENTRICULAR CATHETER
• 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: 9097817
• MDR Text Key: 172862730
• Report Number: 3010611950-2019-00055
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 821731C
• Device Catalogue Number: 821731C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/16/2019
• 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): Life Threatening; Required Intervention