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	05/16/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Monitor is showing incorrect reading (half of camino output is being displayed).Delay in surgery: unknown was there any patient injury/ death alleged: no any revisions/medical interventions required: monitor could not be connected to epic (emr) / local monitor as data incorrect - values had to be manually charted was the patient (s) prepped for surgery: no any delay in surgery due to late receipt of product: no any delay in surgery due to product problem(s): no.
Additional Manufacturer Narrative
On (b)(6) 2018 the customer reported the following: monitor is showing incorrect reading (half of camino output is being displayed).Patient information: 21 year old male; 153kg.Incident date: (b)(6) 2018.Was there any patient injury/ death alleged: no.Any revisions/medical interventions required: monitor could not be connected to epic (emr) / local monitor as data incorrect - values had to be manually charted.Was the patient (s) prepped for surgery: no.Any delay in surgery due to late receipt of product: no.Any delay in surgery due to product problem(s): no.Upon additional followup on (b)(6) 2018 the customer informed us that incorrect readings were due to user error-customer was using the wrong adapter.After customer switched to the correct adaper the issue resolved device will not be returned.No further follow-up needed.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; technology park; sragh tullamore, offaly ; EI
• MDR Report Key: 7593154
• Report Number: 2023988-2018-00031
• Device Sequence Number: 10815424
• Product Code: GWM
• UDI-Device Identifier: 10381780039310
• UDI-Public: 10381780039310
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K121573
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Remedial Action: Modification/Adjustment
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2018

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: Health Professional
• Device Model Number: CAM02
• Device Catalogue Number: CAM02
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/16/2018
• Supplement Date Received by Manufacturer: 05/16/2018
• Initial Report FDA Received Date: 06/12/2018
• Supplement Report FDA Received Date: 08/24/2018
• 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
• Patient Age: 21 YR
• Patient Weight: 153