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

Model Number	1104B
Medical Device Problem Code	Failure to Zero (1683)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Part1104b -olm intracranial pressure monitoring kit - during doctor's robotic seeg (stereoelectroencephalography) case, he wanted to use a natus camino intracranial pressure monitor.When he went to zero it out before use, it remained at a setting of 300 and would not move.He used a different one instead.No injuries reported.
Additional Manufacturer Narrative
Initial report ref natus complaint# (b)(4).Acceptable risk as per hazard id 12.1, severity 0, in doc-047178 camino 110-4 series catheter kits-risk analysis.Risk is considered to be 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 - during doctor's robotic seeg (stereoelectroencephalography) case, he wanted to use a natus camino intracranial pressure monitor.When he went to zero it out before use, it remained at a setting of 300 and would not move.He used a different one instead.No injuries reported.
Additional Manufacturer Narrative
Follow up report 001 natus complaint# (b)(4).Three attempts were made to confirm if the affected product was available to be returned for evaluation on november 8th, 15th and 22nd, 2023.28-nov-2023: completed complaint form returned, confirmed part was available to be returned.Customer was sent another three reminders to return the product on december 14th, 24th and 29th, 2023.Device was not returned for evaluation.Invoice sent january 14th, 2024.No device history record review carried out for this product.Complaint history was reviewed for the previous two years and found 1 confirmed complaint, giving a failure rate of (b)(4)%.Further investigation to be carried out before final closure of complaint case.
Event or Problem Description
Part1104b -olm intracranial pressure monitoring kit - during doctor's robotic seeg (stereoelectroencephalography) case, he wanted to use a natus camino intracranial pressure monitor.When he went to zero it out before use, it remained at a setting of 300 and would not move.He used a different one instead.No injuries reported.
Additional Manufacturer Narrative
Follow up report 002 natus complaint# (b)(4).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.No associated capas.Root cause/failure investigation: the customer did not return the device for evaluation or provide any further information regarding the incident.The device history records show the catheter met specifications prior to release.Failure mode: unconfirmed/ no device returned.

• 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: 18109053
• Report Number: 2023988-2023-00041
• Device Sequence Number: 15382977
• 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,Followup
• Report Date (Section B): 07/19/2024

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
• Operator of Device: Health Professional
• Device Model Number: 1104B
• Device Catalogue Number: 1104B
• Device Lot Number: 118D00960448
• 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: 11/02/2023
• Supplement Date Received by Manufacturer: 11/02/2023; Not provided
• Initial Report FDA Received Date: 11/10/2023
• Supplement Report FDA Received Date: 03/01/2024; 07/19/2024
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 27 YR
• Patient Sex: Female