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

Model Number	CAM02
Medical Device Problem Code	Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Event or Problem Description
From the minimum complaint information form received (b)(4) 2017 from integra lifesciences: "according to customer, monitor is displaying error e2057-sensorboard failure.This happened during a procedure.Monitor is still covered under manufacturer warranty." the form indicated the following; "patient prepped for surgery: yes" "out of box failure(oob): no" "did product fail during commissioning, decontamination or setup procedures prior to first clinical use? no" as no other information regarding the patient and patient impact was provided, a follow-up e-mail was sent (b)(6) 2017 to the user facility requesting additional information.A reply was received on (b)(6) 2017: "was there an injury to the patient? no" "was any medical intervention required? no" "was there a delay in surgery caused by the product issue? no".
Additional Manufacturer Narrative
Added 24 jan 2018: natus completed their investigation on 03 jan 2018.The investigation included: methods: evaluation of the actual device, review of the device history and service history records, review of complaints history/trend analysis, review of past capas/capa determination.Results: cam02 serial number (b)(4) returned to (b)(4) service center for failure analysis.Reason for return: error message e2057-sensorboard failure.The monitor was evaluated on 20-dec-2017 for reported failure.The reported failure was unconfirmed.Despite finding e2063 and e2057 in the log, the technician was unable to duplicate the reported failure (or e2063).The cause may have been the customer's catheter, but we did not have possession of the catheter.As a precautionary measure, i, (b)(4), authorized the technician, (b)(4), to replace the sensor board.Following the replacement, all the monitor passed all functional tests.Per the cam02 service manual 60903842 rev a chapter 4, displayed error code descriptions; cause(s): e2057: "sensor board failure"; icp firmware: supply voltages out of bounds e2063: "temperature sensor failure"; temperature thermistor failure (ground wire broken).The dhr was reviewed and no anomalies that could be associated with the complaint incident were observed.The service history for the device was attached (to the complaint investigation) by the service centre, the summary was reviewed and no anomalies that could be associated with the complaint incident were observed.The number of complaints identified for pr e2057 and the cam02 monitor was verified as not the cause of the complaint incident 9: (b)(4).The complaint was verified as a single occurrence for e2063.Further review is not required, the monitor was verified as not the cause of the complaint incident.Based on the complaint description a review of cam02 monitor customer complaints was completed using the following key word "e2057" in the search criteria.The review encompassed (b)(6) dates (b)(6) 2015 to (b)(6) 2017.A total of (b)(4) complaints were reviewed of which 15 complaints were identified: (b)(4).The complaint reports were reviewed and no anomalies that could be associated with the complaint incident were observed.Additionally, the review verified that this complaint is the second complaint occurrence for the serial number under investigation for this complaint.(b)(4) was previously initiated for reporting an error code e1003-power board failure.The complaint report was reviewed and no anomalies that could be associated with the complaint incident were observed.A statistical analysis was completed to identify if complaint trend review is an adverse complaint trend.No adverse statistical trend has been identified.A review of open capas and capa at (b)(4) 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.The review encompassed (b)(4) dates (b)(6) 2016 to (b)(6) 2017.A total of 6 capa's were reviewed in which none of the capa's were applicable to the complaint incident.Is capa required? no the complaint is now deemed closed.

• Brand Name: CAMINO ICP MONITOR
• Common Device Name: INTRACRANIAL PRESSURE MONITORING DEVICE
• Manufacturer (Section D): INTEGRA LIFESCIENCES (IRELAND) LIMITED; ida business and technology pa; sragh tullamore, offaly ; EI
• MDR Report Key: 7149861
• Report Number: 2023988-2017-00514
• Device Sequence Number: 1994460
• Product Code: GWM
• UDI-Device Identifier: 10381780039310
• UDI-Public: 10381780039310
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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: Biomedical Engineer
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date (Section B): 12/27/2017

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: No Information
• Device Model Number: CAM02
• Device Catalogue Number: CAM02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 11/27/2017
• Initial Report FDA Received Date: 12/27/2017
• Supplement Report FDA Received Date: 01/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1