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

Model Number	1104B
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial report (ref natus complaint# (b)(4).When implanting the new mpic, an error message appeared on the display.The monitor was changed to test the mpic and the error remained.There was a request for a new mpic in the pharmacy to implant it in the patient and it worked normally.Reference: 110-4b lot: 118d00246058 / (b)(6): (b)(4) / validate: 11/04/2022 in this way, the error message: "catheter not detected" occurred 3 times with 3 units of the material item that were implanted.The situation was investigated, talked with those involved and observed that this is not a bad professional technique.There was no patient injury.Customer confirmed they are unable to return the product as it was disposed of onsite.Review of product evaluation form shows no associated capas.Complaint history was reviewed for the previous two years and found 3 confirmed complaints, giving an incident rate of (b)(4).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.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.No complaint trends have been identified.Acceptable risk associated with the complaint as per line 5.10 (b)(4) camino icp monitor risk analysis.Service repair investigations will be conducted during the repair process and trend data will be reviewed per (b)(4).Failure confirmed: no.Investigation result code: (b)(4) |eds products|no return of device for evaluation closure rationale: complaint could not be verified, materials not returned for analysis.Other closure rationale: low safety risk of harm, individual complaint related to issue stated.Complaint will be included in trending data for further review and investigation if needed.
Event or Problem Description
Customer states their system shows an error message when implanting mpic.Resolution was found after swapping mpic.No patient injury.

• 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
• MDR Report Key: 11722605
• Report Number: 2023988-2021-00006
• Device Sequence Number: 1021320
• Product Code: GWM
• UDI-Device Identifier: 00382830047494
• UDI-Public: 00382830047494
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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
• Report Date (Section B): 04/07/2021

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: 118D00246058
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/07/2021
• Initial Report FDA Received Date: 04/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1