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U.S. Department of Health and Human Services

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

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NATUS NEURO INCORPORATED EDS-3 COMPLETE (STERILE) WITHOUT VENTRICULAR CATHETER Back to Search Results
Model Number 821731C
Device Problem Failure to Disconnect (2541)
Patient Problem Cerebrospinal Fluid Leakage (1772)
Event Date 12/12/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Device from different lot tested. Unable to reproduce failure observed by complaint.
 
Event Description
Drainage bag broke off at the luer lock connection site.
 
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Brand NameEDS-3 COMPLETE (STERILE) WITHOUT VENTRICULAR CATHETER
Type of DeviceEDS-3
Manufacturer (Section D)
NATUS NEURO INCORPORATED
3150 pleasant view road
middleton WI 53562
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 Key8241534
MDR Text Key132942438
Report Number3010611950-2018-00003
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K162437
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 12/12/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/11/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/30/2021
Device Model Number821731C
Device Catalogue Number821731C
Device Lot Number206224
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/12/2018
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? Yes
Type of Device Usage Initial

Patient Treatment Data
Date Received: 01/11/2019 Patient Sequence Number: 1
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