MAUDE Adverse Event Report: NATUS MEDICAL INCORPORATED (CAMINO) OLM INTRACRANIAL PRESSURE MONITORING KIT; INTRACRANIAL PRESSURE MONITORING DEVICE

Model Number	110-4B
Medical Device Problem Code	Device Sensing Problem (2917)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/12/2018
Type of Reportable Event	Malfunction
Event or Problem Description
The following was reported by a user facility in (b)(6): for 2 patients the camino icp probes showed significant deviations in the values compared to already existing measurements (evd).Medical device failure: yes.Product in contact with patient? : yes.Is patient injury or death alleged?: no.Did the event lead to significant increase in surgery time? : no.Is product being returned?: yes.Additional information has been requested.
Additional Manufacturer Narrative
Follow-up #1 (b)(6) 2019: corrected data: -lot number for device.-street name contact office and manufacturing site.Added data: -expiration date for device.-device manufacture date.Additional incident information received: -on (b)(6) 2018, a user facility adverse event report was received from bfarm.It provided the following additional information regarding the incident (translated from german): "both camino probes show extreme differences of the icp in comparison to already existing measure." related device complaint number and mdr: (b)(4).Based on the incident information provided by the reporters as well as examination of the returned device, natus has completed its investigation.The investigation included: methods: -evaluation of actual device, -review of complaints history, -device history record review, -review of past capas/capa determination.Results: -the returned device showed evidence of use.The device was functionally tested and the catheter met performance criteria.-based on the complaint description, a review of complaints was performed using the following key words "integ-reading" in the search criteria.The review of catheter complaints from nov-2016 through nov-2018 found three (3) confirmed complaints during this time.-the dhr for the catheter was reviewed and no anomalies that could be associated with the complaint incident were observed.-a review of capas initiated within the past 24 months were reviewed to determine if any capas were generated specifically related to the customer's complaint.The review found zero (0) capas where the scope is related to this complaint incident.Based on incident rate and assessed risk captured in the risk management file, no capa initation required.The complaint was not confirmed and is now considered closed.

• Brand Name: (CAMINO) OLM INTRACRANIAL PRESSURE MONITORING KIT
• Common Device Name: INTRACRANIAL PRESSURE MONITORING DEVICE
• Manufacturer (Section D): NATUS MEDICAL INCORPORATED; 5955 pacific center blvd; san diego CA 92121
• MDR Report Key: 7778446
• Report Number: 2023988-2018-00043
• Device Sequence Number: 11082643
• Product Code: GWM
• UDI-Device Identifier: 10381780023623
• UDI-Public: 10381780023623
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K102875
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2018

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: Other
• Device Expiration Date: 02/11/2020
• Device Model Number: 110-4B
• Device Catalogue Number: 1104B
• Device Lot Number: 111DRX372993
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2018
• Initial Date Received by Manufacturer: 07/16/2018
• Supplement Date Received by Manufacturer: 07/16/2018
• Initial Report FDA Received Date: 08/13/2018
• Supplement Report FDA Received Date: 01/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1