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

Model Number	1104B
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reference (b)(4).Customer asked to provide follow up information regarding incident and return of device on (b)(6) 2019.Product was returned to lab for decontamination, once complete will be sent to natus for additional evaluation.
Event or Problem Description
Catheter gave high readings compared to evd.

• Brand Name: CAMINO ICP
• Common Device Name: OLM INTRACRANIAL PRESSURE MONITORING KIT
• Manufacturer (Section D): NATUS NEURO INCORPORATED; 5955 pacific center boulevard; san diego CA 92121
• MDR Report Key: 8962499
• Report Number: 3010611950-2019-00050
• Device Sequence Number: 2859493
• Product Code: GWM
• UDI-Device Identifier: 10381780023623
• UDI-Public: 10381780023623
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 08/12/2019

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
• Device Lot Number: 383125-D06
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/12/2019
• Initial Report FDA Received Date: 09/04/2019
• 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