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

Model Number	1104B
Medical Device Problem Codes	Display or Visual Feedback Problem (1184); Temperature Problem (3022)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial report natus complaint (b)(4).Per (b)(4) rev 05 camino 110-4 series catheter kits-risk analysis spreadsheet (ras) hazard id 12.1.Cause - nonfunctional product/inability to set zero prior to use: non-robust fiber design or materials / for intended use.Effect (harm)- minor delay in patient treatment residual risk - minor.The hazards identified have been reduced as far as possible, and the benefit of use of the entire product outweighs the risks identified.It has yet to be confirmed if the affected catheter and the related cam02 serial# (b)(6) will be returned to natus.Further investigation to be carried out.
Event or Problem Description
Part1104b -olm intracranial pressure monitoring kit - 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.
Additional Manufacturer Narrative
Follow up report 001 ref natus complaint# (b)(4).No associated capas.Complaint history review/trend analysis: (24 months review and percent of sales) 1 previously confirmed "integ-reading" complaints within the past two years.(b)(4) units sold within past two years.Failure rate =(b)(4).Root cause/failure investigation: the customer did not return the device for evaluation or provide any further information regarding the alleged complaint.Failure mode: no device returned - unable to determine.
Event or Problem Description
Part1104b -olm intracranial pressure monitoring kit - 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: 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 92121
• Manufacturer Contact: gráinne walsh ; 5955 pacific center boulevard; san diego 92121
• MDR Report Key: 20831436
• Report Number: 2023988-2024-00091
• Device Sequence Number: 8864980
• 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): 01/09/2025

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/04/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/03/2024
• Supplement Report FDA Received Date: 01/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Sex: Male