MAUDE Adverse Event Report: NATUS MEDICAL INC. DBA INTEGRA NEUROSCIENCES (CAMINO) OLM INTRACRANIAL PRESSURE MONITORING KIT; INTRACRANIAL PRESSURE MONITORING DEVICE

Model Number	110-4B
Medical Device Problem Codes	Unable to Obtain Readings (1516); Device Issue (2379)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Event or Problem Description
The following was reported by a foreign user facility: "the hospital informed the catheter stopped the measurement during the use" additional information has been requested.
Additional Manufacturer Narrative
Additional information: no patient injury.Four attempts were made to obtain additional information on this incident, however there has been no response: additional information requested: 04april2018-no response.Additional information requested: 19april2018-no response.Additional information requested: 02may2018-no response.Additional information requested 15may2018- no response.Natus completed their investigation on (b)(6) 2018.The results included the reference: device history record review.Review of past capas/ capa determination.Review of complaints history/trend analysis.Risk management review.Results: 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.Capa complaint log 201 6, 2017 reviewed on 07-apr-2018 specific for the complaint issue under investigation indicates that there no capa investigation related to this catheter complaint.No capa has been issued in 2018.There were twelve (12) confirmed complaint during apr-2016 through mar-2018 under complaint code "integimproper function".The numbers of catheter sold during this time, (81036) shows an incidence rate of 0.015%.The failure mode resulted in a "delay in patient treatment" (ids-b-bt-l-ooi ).A review of the camino risk management file has identified the failure mode of "does not measure intracranial pressure accurately" (ids-b-bt-l-ooi ), this is based on the complaint description.It can be concluded that the impact of the failure of the 110-4bt catheter resulted in a "delay in patient treatment" (ids-b-bt-l-ooi ).: the reported customer complaint could not be replicated.Root cause: based on the results of this investigation, the root cause of the reported customer complaint could not be determined at this time.No corrective action required based on the evaluation above.Trends will be monitored for this or similar complaints.Multiple attempes were made to obtain additional information from the customer, however there has been no response.This complaint is now deemed closed, should additional information be received, the complaint may be reopened.

• Brand Name: (CAMINO) OLM INTRACRANIAL PRESSURE MONITORING KIT
• Common Device Name: INTRACRANIAL PRESSURE MONITORING DEVICE
• Manufacturer (Section D): NATUS MEDICAL INC. DBA INTEGRA NEUROSCIENCES; 5955 pacific center blvd.; san diego CA 92121
• MDR Report Key: 7444531
• Report Number: 2023988-2018-00014
• Device Sequence Number: 1963738
• Product Code: GWM
• UDI-Device Identifier: 10381780023623
• UDI-Public: 10381780023623
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: 110-4B
• Device Catalogue Number: 110-4B
• Device Lot Number: 266190-B09
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/21/2018
• Supplement Date Received by Manufacturer: 03/21/2018
• Initial Report FDA Received Date: 04/19/2018
• Supplement Report FDA Received Date: 05/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention