MAUDE Adverse Event Report: NATUS MEDICAL INCORPORATED CAMINO; DEVICE, MONITORING, INTRACRANIAL PRESSURE

Model Number	CAM02
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Patient on camino icp monitor.Patient was placed flat for care, camino with bolt intact.Patient had been for icp (increased intracranial pressure) range 3-5 jumped to 18-19, no change in patients' assessment.Hob (head of bed) elevated wave consistent, then flatted.Resident called natus 24/7 clinical support.During troubleshooting the screen presented temperature numbers ¿ [redacted name] does not use temperature integration.The screen then flashed out of the temperature range.Due to the concern of the screen and inflated numbers -bolt removed.Both the camino and bolt are being sent to the company for further inspection.

• Brand Name: CAMINO
• Common Device Name: DEVICE, MONITORING, INTRACRANIAL PRESSURE
• Manufacturer (Section D): NATUS MEDICAL INCORPORATED; 5955 pacific center blvd; san diego CA 92121
• MDR Report Key: 20599744
• Report Number: 20599744
• Device Sequence Number: 15689273
• Product Code: GWM
• UDI-Device Identifier: 00382830049023
• UDI-Public: (01)00382830049023(11)22020
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/19/2024
• Report Date (Section F): 09/19/2024

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
• Device Model Number: CAM02
• Device Catalogue Number: CAM02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2024
• Was the Report Sent to FDA?: Yes
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 11/04/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/04/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Sex: Male
• Date Report Sent to FDA: 09/19/2024