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

Model Number	1104B
Medical Device Problem Codes	Inaccurate Information (4051); Imprecise or Erratic Results (4059)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/26/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Part1104b -olm intracranial pressure monitoring kit -icp reading > 300, catheter would not read an accurate icp.It was confirmed the part was in contact with the patient, however there was no delay in surgery or additional medical intervention required.
Additional Manufacturer Narrative
Initial report ref natus complaint# (b)(4).Customer confirmed they do not have the packaging to confirm the lot number.31-jul-2023: technical support emailed the customer with information/shipping label on how to return the affected product.There are no capa's related to this issue and this complaint does not identify a deficiency in the product design and therefore a capa is not required.Acceptable risk as per hazard id 12.11 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 -icp reading > 300, catheter would not read an accurate icp.It was confirmed the part was in contact with the patient, however there was no delay in surgery or additional medical intervention required.
Additional Manufacturer Narrative
Follow up report 001 ref natus complaint# (b)(4).Complaint history was reviewed for the previous two years and found 0 confirmed complaints, giving a failure rate of (b)(4)%.The product was received in house.The catheter would connect but did not give an accurate reading.Cam02 (db 4219) showed 311 mmhg and would not change with pot movement.Attempted to restart cam02 and reconnect cables without success.No further testing performed.Root cause/failure investigation: the complaint was confirmed, the returned catheter was found to have sustained damage to the optical fiber by excessive bend.The device history record for the catheter was reviewed; there were no anomalies observed during the manufacturing, packaging, or inspection of the device or accessories while in process.Catheter was likely damaged due to mishandling by the user.The instructions for use precautions the user that "extreme bending and/or kinks can impair the performance of the fiber optic pressure transducer and to exercise caution when handling the catheter.Device failed to meet specifications: yes failure mode: confirmed/ damaged fiber complaint verified, being tracked as a trend.Complaint will be included in trending data for further review.

• 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 CA
• Manufacturer (Section G): NATUS MANUFACTURING LIMITED; ida business park; gort; galway h91pd92, ; EI
• Manufacturer Contact: grainne walsh ; 5955 pacific center boulevard; san diego, 92121, CA
• MDR Report Key: 17547558
• Report Number: 2023988-2023-00023
• Device Sequence Number: 15119615
• Product Code: GWM
• UDI-Device Identifier: 00382830047494
• UDI-Public: 00382830047494
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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): 10/05/2023

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: 118D00947346
• 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: 07/26/2023
• Supplement Date Received by Manufacturer: 07/26/2023
• Initial Report FDA Received Date: 08/15/2023
• Supplement Report FDA Received Date: 10/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/30/2023
• 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