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

Model Number	CAM02
Medical Device Problem Code	Device Operational Issue (2914)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Event or Problem Description
From the minimum complaint information form received (b)(6) 2017 from integra lifesciences: customer stated that the, touch screen locked up.Also indicated on the above mentioned form: out of box failure(oob): no.Did the product fail during commissioning, decontamination or setup procedures prior to first clinical use? no.As no information regarding the patient or potential impact on the patient was provided, a follow-up e-mail was sent by (b)(4) on (b)(6) 2017 requesting further information.
Additional Manufacturer Narrative
As a response was not received for the initial request for additional information related to the event and patient, a second request was sent to the initial reporter and the following was the response received on 19 jan 2018: "to my knowledge there was no incident reported and therefore no information supplied to me.No patient harm was reported no doctor info nothing.I was asked to check out a unit with no touchscreen response and i was able to duplicate the problem and sent it in." natus completed their investigation on 18 jan 2018.The investigation included: methods: evaluation of the actual device and returned accessory devices (including pmio cable, battery, camcabl and monpwr).Review of device history and service history records.Review of complaints history/trend analysis.Review of past capas/capa determination.Results: the monitor was evaluated on 10 january 2018 for reported failure.The reported failure was confirmed.The monitor's touchscreen would not respond to touch or stylus due to the air gap issue.Replaced display screen assembly.Passed all functional tests.The complaint evaluation confirmed the touchscreen was faulty due to an air gap incident.The air gap causes an intermittent contact between the touch surfaces thus causing failure of the screen to work as reported.Based on the complaint investigation completed and the verification the touchscreen failure is the "air gap failure" no further evaluation is deemed necessary.The dhr was reviewed and no anomalies that could be associated with the complaint incident were observed.The service history for the device attached by the service centre was reviewed and no anomalies that could be associated with the complaint incident were observed.Based on the complaint description a review of cam02 monitor customer complaints was completed using the following key words "touchscreen" in the search criteria.The review encompassed pr 140866 to pr 176330 dates 13-dec-15 to 13-dec-17.A total of 260 complaints were reviewed of which 98 complaints were identified.Additionally, the review verified that this complaint is the single complaint occurrence for the serial number under investigation for this complaint.A statistical analysis and ncr review is not required based on the capa.(b)(4) investigated touchscreen air gap failures and is now closed; the corrective actions for the touchscreen air gap instances were addressed as part of the capa activities.The cam02 monitor for this complaint was verified as pre capa activities.No further actions are deemed necessary.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: 7151654
• Report Number: 2023988-2017-00516
• Device Sequence Number: 13827223
• Product Code: GWM
• UDI-Device Identifier: 10381780039310
• UDI-Public: 10381780039310
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 12/28/2017

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: 01/05/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/30/2017
• Supplement Date Received by Manufacturer: 11/30/2017
• Initial Report FDA Received Date: 12/28/2017
• Supplement Report FDA Received Date: 01/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1