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

Model Number	CAM02
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Calibration Problem (2890)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/13/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Camino (b)(4) system requires an annual service/calibration.Also reported that they recently used this monitor on a patient and it was reading 300 mmhg, when changed to a different monitor the readings were normal.Date of incident: (b)(6) 2018.Device in contact with patient: yes.Patient injury/ death alleged: no.Revision/medical intervention required: unk.Patient prepped for surgery: no.Patient information: unknown.Delay in surgery due to late receipt of product: no.Delay in surgery due to product problem: unk.Out of box failure (oob): no.Additional information will be requested.
Additional Manufacturer Narrative
Natus completed their investigation on (b)(6) 2018.The investigation included: methods: review of device history and service records.Review of past capas capa determination.Review of complaints history and complaint rate.Results: the customer's complaint "due for servicing and they think it has a calibration issue which also needs checking, it doesn't zero.Also reported they recently used this monitor on a patient and it was reading 300mmhg, when changed to a different monitor the readings were normal" could not be confirmed.The monitor's battery was expired and required replacement and well as the lithium battery.The unit met the functional and safety testing and calibrated without issue.The dhr was reviewed and no anomalies that could be associated with the complaint incident were observed, dhr record is attached.Date of manufacture: 2014-feb.A review of the cam02 relationship of device characteristics to hazards (table a) rev.1 hazard dia-ooi identifies an incident when the cam02 monitor displays an inaccurate or unavailable icp measurement (mean icp or waveform).The cam02 medical device hazard analysis (rev.B) this incident result is scored as follows: severity of harm: negligible description: a review of capa's initiated within the past 12 months, open capas was completed specifically related to the complaint was completed to determine if a similar complaint is either under active capa investigation or have been previously addressed through a capa none of the capa's scope were considered related to the complaint incident.Complaint history, model cam02, from feb-2016 through feb-2018 reviewed; there were three (3) other confirmed complaints with the complaint code of "high reading".Based on the number of cam02xx sold, (2337), units multiplied by 100, results in a failure rate percentage 0.128% a review of the cam 02 risk management file has identified the failure mode of "inaccurate or unavailable icp measurement (mean icp or waveform)" (dia-ooi), this is based on the complaint description, with a negligible rate of harm.No action is required at this time, however the customer's complaint is reviewed during the quarterly qmrs to monitor for tends.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: 7343241
• Report Number: 2023988-2018-00009
• Device Sequence Number: 11340973
• Product Code: GWM
• UDI-Device Identifier: 10381780039310
• UDI-Public: 10381780039310
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 03/14/2018

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?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/27/2018
• Supplement Date Received by Manufacturer: 02/14/2018
• Initial Report FDA Received Date: 03/15/2018
• Supplement Report FDA Received Date: 06/29/2018
• 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