MAUDE Adverse Event Report: NATUS NEURO INCORPORATED CODMAN LUMBAR EXTERNAL DRAINAGE KIT; CODMAN EDS3 DRAINAGE SYSTEM

Model Number 821706

Device Problem No Device Output (1435)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/13/2019

Event Type  malfunction  

Manufacturer Narrative

Reference (b)(4).No device return or updated information provided despite requests made on 14-feb-2019, 25-feb-2019 and 12-mar-2019.

Event Description

Customer missing leveling device from unit, eyeballed drainage and states unit is not properly draining.

• Brand Name: CODMAN LUMBAR EXTERNAL DRAINAGE KIT
• Type of Device: CODMAN EDS3 DRAINAGE SYSTEM
• 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 Key: 8413674
• MDR Text Key: 139193119
• Report Number: 3010611950-2019-00014
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061568
• 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: 02/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 821706
• Device Catalogue Number: 821706
• Device Lot Number: 209015
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/13/2019
• 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