MAUDE Adverse Event Report: NATUS NEURO INCORPORATED CAMINO ICP; OLM INTRACRANIAL PRESSURE MONITORING KIT

Model Number	1104B
Medical Device Problem Code	Unable to Obtain Readings (1516)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reference (b)(4).Additional information to be provided if product returns.Product used at the same time as cam02 unit.Reference mdr 3010611950-2019-00028 for catheter information, reference mdr 3010611950-2019-00030 for monitor information.
Event or Problem Description
Catheter shows to have failed on monitor after insertion.

• Brand Name: CAMINO ICP
• Common Device Name: OLM INTRACRANIAL PRESSURE MONITORING KIT
• Manufacturer (Section D): NATUS NEURO INCORPORATED; 3150 pleasant view road; middleton WI 53562
• MDR Report Key: 8533478
• Report Number: 3010611950-2019-00028
• Device Sequence Number: 1836951
• Product Code: GWM
• UDI-Device Identifier: 10381780023623
• UDI-Public: 10381780023623
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Report Date (Section B): 04/05/2019

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 Model Number: 1104B
• Device Catalogue Number: 1104B
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/05/2019
• 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