MAUDE Adverse Event Report: NATUS NEURO INCORPORATED CAMINO 1104B CATHETER; OLM INTRACRANIAL PRESSURE MONITORING KIT

Model Number	1104B
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reference (b)(4).Additional information will be provided if product is returned.
Event or Problem Description
Outer hub did not properly secure to the probe.
Additional Manufacturer Narrative
Device evaluated.Catheter found to be functioning as intended therefore unable to verify complaint.

• Brand Name: CAMINO 1104B CATHETER
• Common Device Name: OLM INTRACRANIAL PRESSURE MONITORING KIT
• Manufacturer (Section D): NATUS NEURO INCORPORATED; 3150 pleasant view road; middleton WI 53562
• MDR Report Key: 8544759
• Report Number: 3010611950-2019-00032
• Device Sequence Number: 400722
• Product Code: GWM
• UDI-Device Identifier: 10381780023623
• UDI-Public: 10381780023623
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K102875
• 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,Followup
• Report Date (Section B): 04/18/2019

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 Expiration Date: 01/07/2022
• Device Model Number: 1104B
• Device Catalogue Number: 1104B
• Device Lot Number: 118D00077012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2019
• Initial Date Received by Manufacturer: 04/18/2019
• Supplement Date Received by Manufacturer: 04/18/2019
• Initial Report FDA Received Date: 04/24/2019
• Supplement Report FDA Received Date: 05/30/2019
• 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