MAUDE Adverse Event Report: NATUS MEDICAL INCORPORATED OLM INTRACRANIAL PRESSURE MONITORING KIT

Model Number	1104B
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial report ref to natus complaint#: (b)(4).No delay in surgery.No medical intervention required.Incident occurred prior to catheter zero and insertion.Per (b)(4) rev 06 camino 110-4 series catheter kits-risk analysis spreadsheet (ras) hazard 12.17 - does not measure intracranial pressure accurately: a) user incorrectly implants catheter.B) user damages catheter during insertion.Effect (harm): delay in patient treatment.Residual risk: minor.The hazards identified have been reduced as far as possible, and the residual risk for these hazards is mainly associated with improper use of device.The device's ifu states precautions in order to use the device.Further investigation to be carried out.
Event or Problem Description
Nt821731c - camino bolt placement resulted in pieces broken/malfunctioned.

• Brand Name: OLM INTRACRANIAL PRESSURE MONITORING KIT
• Common Device Name: OLM INTRACRANIAL PRESSURE MONITORING KIT
• Manufacturer (Section D): NATUS MEDICAL INCORPORATED; 5955 pacific center boulevard; san diego CA 92121
• Manufacturer Contact: 5955 pacific center boulevard; san diego, CA 92121
• MDR Report Key: 25196268
• Report Number: 2023988-2026-00065
• Device Sequence Number: 16054671
• Product Code: GWM
• UDI-Device Identifier: 00382830047494
• UDI-Public: 00382830047494
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K102875
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2026

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: 118H01160066
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/01/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/17/2026
• Supplement Report FDA Received Date: 06/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/19/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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 Sex: Male