MAUDE Adverse Event Report: NATUS NEURO INCORPORATED CAMINO ICP; CAMINO ICP MONITORING CATHETER W/ LICOX BOLT FIT

Model Number	1104L
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reference (b)(4).Dhr review shows no anamolies.
Event or Problem Description
Catheter failed after installation, requiring a new one.

• Brand Name: CAMINO ICP
• Common Device Name: CAMINO ICP MONITORING CATHETER W/ LICOX BOLT FIT
• Manufacturer (Section D): NATUS NEURO INCORPORATED; 3150 pleasant view road; middleton WI 53562
• MDR Report Key: 8533472
• Report Number: 3010611950-2019-00023
• Device Sequence Number: 16577251
• Product Code: GWM
• UDI-Device Identifier: 10381780023661
• UDI-Public: 10381780023661
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K121573
• 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
• Report Date (Section B): 11/06/2018

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: 02/08/2021
• Device Model Number: 1104L
• Device Catalogue Number: 1104L
• Device Lot Number: 111D00376228
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/06/2018
• Initial Report FDA Received Date: 04/19/2019
• 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
• Patient Age: 31 YR