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

Model Number	1104B
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Part1104b -olm intracranial pressure monitoring kit - patient had single lumen intracranial bolt inserted overnight, required use of camino monitor for icp (intracranial pressure) readings.When catheter inserted and connected to camino, "catheter error" message was received.Staff attempted to use second camino monitor, received same error message "catheter failure".Patient required surgery and was sent to the or with the catheter in place, secondary portion of monitoring device was kept, catheter was discarded.
Additional Manufacturer Narrative
Initial report ref natus complaint (b)(4).There are no capa's related to this issue.Per (b)(4) complaint histories are reviewed routinely per quality system requirements and any complaint trends are assessed and documented as part of these reviews.Per (b)(4) camino pressure monitoring catheter kits-risk analysis spreadsheet, hazard id - 12.1, the risk is considered low.A risk review is not required as this complaint does not describe a new failure mode or new harm and the existing hazard severity and/or probability of occurrence has not changed.Further investigation to be carried out.
Event or Problem Description
Part1104b -olm intracranial pressure monitoring kit - patient had single lumen intracranial bolt inserted overnight, required use of camino monitor for icp (intracranial pressure) readings.When catheter inserted and connected to camino,"catheter error" message was received.Staff attempted to use second camino monitor, received same error message "catheter failure".Patient required surgery and was sent to the or with the catheter in place, secondary portion of monitoring device was kept, catheter was discarded.
Additional Manufacturer Narrative
Follow up report 001 ref natus complaint# (b)(4).Correction to section d4, lot 118d00643292, serial (b)(6).The device history record was reviewed, the raw materials used in the manufacturing met specifications and there were no anomalies observed during the manufacturing , packaging, or inspection of the device in process.Complaint history review: 1 previously confirmed 'integ-improper function' complaints within the past two years.The complaint could not be confirmed, the device was returned and functionally tested, meeting specifications.The complaint could not be duplicated, catheter functioned as intended.Failure mode: unconfirmed / catheter met specification, no fault found.

• 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 (Section G): NATUS MANUFACTURING LIMITED; ida business park; gort; galway, H91PD 92; EI H91PD92
• Manufacturer Contact: gráinne walsh ; 5955 pacific center boulevard; san diego, CA 92121
• MDR Report Key: 18187372
• Report Number: 2023988-2023-00042
• Device Sequence Number: 6542191
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/24/2025
• Device Model Number: 1104B
• Device Catalogue Number: 1104B
• Device Lot Number: 118D00643292
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/20/2023
• Supplement Date Received by Manufacturer: 10/20/2023
• Initial Report FDA Received Date: 11/21/2023
• Supplement Report FDA Received Date: 02/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/31/2022
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown