MAUDE Adverse Event Report: NATUS NEURO INCORPORATED CAMINO ICP; SUBDURAL POST CRANIOTOMY ICP MONITORING KIT

Model Number	1104G
Medical Device Problem Code	Unable to Obtain Readings (1516)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reference (b)(4).Customer asked to return product for additional evaluation.
Event or Problem Description
Catheter suddenly stopped monitoring 3 days after implanted.

• Brand Name: CAMINO ICP
• Common Device Name: SUBDURAL POST CRANIOTOMY ICP MONITORING KIT
• Manufacturer (Section D): NATUS NEURO INCORPORATED; 5955 pacific center boulevard; san diego CA 92121
• MDR Report Key: 9097785
• Report Number: 3010611950-2019-00053
• Device Sequence Number: 2802132
• Product Code: GWM
• UDI-Device Identifier: 10381780025511
• UDI-Public: 10381780025511
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K962928
• 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): 09/03/2019

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: 1104G
• Device Catalogue Number: 1104G
• Device Lot Number: 377503-H09
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/03/2019
• Initial Report FDA Received Date: 09/20/2019
• 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: 62 YR