MAUDE Adverse Event Report: INTEGRA LIFESCIENCES (IRELAND) LIMITED INTEGRA CAMINO ICP MONITOR; INTRACRANIAL PRESSURE MONITORING DEVICE

Model Number	CAM02
Medical Device Problem Code	Invalid Sensing (2293)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/19/2018
Type of Reportable Event	Malfunction
Event or Problem Description
The monitor is showing wrong results.Used other device.Delay in surgery due to product problem? no.Part/product being returned? yes.Additional information has been requested.
Additional Manufacturer Narrative
Additional information received 13june2018: no patient harm from this incident.Several attempts were made to obtain patient information, however the requests have been unsuccessful: follow-up: 08may2018, follow-up: 09may2018, and follow-up 04june2018.Natus completed their evaluation on 13july2018.The investigation included the following methods: review of device history records and service records.Review of complaints history and complaint rate.Review of past capas and capa determination.Dhr review: the dhr was reviewed and no anomalies that could be associated with the complaint incident were observed.The device was manufactured on: feb-2013.The service report shows the unit was calibrated and retested meeting specifications prior to return to the customer.Complaint history review/ trend analysis: based on the complaint description a review of complaints was completed using the following key word ' integra-reading" in the search criteria.The review encompassed dates jun-2016 through may-2018.There were 17 confirmed complaints during this time.Based on the number of sales (during this period jan-2016 to may-2018), (b)(4), this complaint code (reason) has an incident rate (b)(4).Risk management review: a review of the cam02 medical device hazard analysis (table b) identifies the hazard for the customers complaint" inaccurate or unavailable icp measurement (mean icp or waveform)" as "inconvenience to user" (hazard id # dia-ooi ) with a severity of "negligible".Capa: n/a (no capa since nov-2016).Root cause: no fault found.Did the device likely contribute to reported incident or adverse event? no.This complaint is now deemed closed.

• Brand Name: INTEGRA CAMINO ICP MONITOR
• Common Device Name: INTRACRANIAL PRESSURE MONITORING DEVICE
• Manufacturer (Section D): INTEGRA LIFESCIENCES (IRELAND) LIMITED; ida business and tech. park; sragh tullamore, offaly ; EI
• MDR Report Key: 7569225
• Report Number: 2023988-2018-00029
• Device Sequence Number: 1317250
• Product Code: GWM
• UDI-Device Identifier: 10381780039310
• UDI-Public: 10381780039310
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K121573
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other
• Remedial Action: Other,Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2018

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: CAM02
• Device Catalogue Number: CAM02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/08/2018
• Supplement Date Received by Manufacturer: 05/08/2018
• Initial Report FDA Received Date: 06/05/2018
• Supplement Report FDA Received Date: 07/18/2018
• 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