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

Model Number	CAM02
Medical Device Problem Code	Unable to Obtain Readings (1516)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was returned to the service centre for evaluation.The reported failure was not confirmed.During the incoming test, the unit passed all tests, and the reported failure was unable to be duplicated.Performed functional tests and the monitor passed all functional tests.In addition to testing a review of the dhr was performed and no anomalies associated with the complaint incident were found.A review of non-conformance reports (ncrs) is deemed necessary as the root cause of the complaint incident was not determined due to no fault found.There is no evidence of a manufacturing defect.Further incidents of this nature will be monitored for recurrence and trending purposes.Reviews of complaint trends and capas were also performed.There were no capas found related to this event.A total of (b)(4) complaints were reviewed of which the complaint was identified as a single occurrence.Additionally, the review verified that this complaint is the single complaint occurrence for the serial number under investigation.
Event or Problem Description
Customer stated unit will not produce reading.Further information supplied by reporter: out of box failure: no.Did product fail during commissioning, decontamination or setup procedures prior to first clinical use: no.Additional information requested.
Additional Manufacturer Narrative
Added 21 jan 2018.As no further information related to the event (date, patient, etc.) will be able to be obtained, the complaint is now considered closed.
Event or Problem Description
Update 21 jan 2018.A request was made 13 dec 2017 for patient information.A response was received later that day."not the end user.Am third party biomed.Unit was found in shop when i arrived.Duration in shop over 6 months.Unable to provide this information." as there is no information related to the patient or actual incident, the report is being updated from an "adverse event" to a "product problem".

• 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: 7036038
• Report Number: 2023988-2017-00505
• Device Sequence Number: 13895617
• Product Code: GWM
• UDI-Device Identifier: 10381780039310
• UDI-Public: 10381780039310
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2017

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/17/2017
• Supplement Date Received by Manufacturer: 10/17/2017
• Initial Report FDA Received Date: 11/15/2017
• Supplement Report FDA Received Date: 01/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1