MAUDE Adverse Event Report: NATUS MEDICAL INCORPORATED (CAMINO) OLM INTRACRANIAL PRESSURE MONITORING KIT; INTRACRANIAL PRESSURE MONITORING DEVICE

Model Number	110-4B
Medical Device Problem Code	Pressure Problem (3012)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/25/2018
Type of Reportable Event	Malfunction
Event or Problem Description
The following was reported by a user facility in (b)(4): "loss of the pressure signal introduction of the catheter in the trepan.Changed the catheter.Clinical consequences found? nothing to report." no additional information provided.

• Brand Name: (CAMINO) OLM INTRACRANIAL PRESSURE MONITORING KIT
• Common Device Name: INTRACRANIAL PRESSURE MONITORING DEVICE
• Manufacturer (Section D): NATUS MEDICAL INCORPORATED; 5955 pacific center blvd.; san diego CA 92121
• MDR Report Key: 7744743
• Report Number: 2023988-2018-00042
• Device Sequence Number: 1280927
• Product Code: GWM
• UDI-Device Identifier: 10381780023623
• UDI-Public: 10381780023623
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K102875
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Pharmacist
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 08/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 110-4B
• Device Catalogue Number: 1104B
• Device Lot Number: 357877-C11
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2018
• Initial Report FDA Received Date: 08/02/2018
• 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: Required Intervention