MAUDE Adverse Event Report: INTEGRA LIFESCIENCES(IRELAND) INTER-CRANIAL PRESSURE AND TEMPERATURE MONITOR; ICP MONITORING

Catalog Number CAM02

Device Problems No Device Output (1435); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

It was reported that the device failed every three month checkup.There was no patient injury and no revision/medical intervention required.Additional information has been requested.

Manufacturer Narrative

Integra has completed their internal investigation on 03/28/2017.The investigation included: methods: evaluation of actual device.Review of device history records.Review of complaints history.Results: error code e0011 occurred at the service center when the device was evaluated.The error code occurs due to a communication failure between the device pc and the sensor board.For this evaluation, the service center confirmed the sensor board was the cause of the complaint incident.Based on the evaluation performed at the service centre further evaluation is not required.The complaint can be closed as valid, future incidents of this nature will be documented for recurrence and trending purposes.The dhr review was completed for cam02 monitor serial number (b)(4).Date of manufacture: 2014 - sep.Dhr review verified no anomalies that could be associated with the complaint were observed.All the functionality tests were carried out accordingly and all results of the tests were recorded as within specification prior to the cam02 monitor been released.The service history review verified no anomalies that could be associated with the complaint were observed.Rate of occurrence: during the time period ¿feb 16 to feb 17¿, the global product usage for cam02 monitors combined was calculated as (b)(4) usages, using the total quantity of cam02 monitor catheter sales sold to calculate the quantity of usages.One catheter is used per procedure, and is used as a means of quantifying the number of procedures undertaken.The quantity of complaints in the complaint review (1) can therefore be calculated as (b)(4) (remote) of procedures.This percentage is within the expected rate of occurrence scored in the pre-mitigation risk estimate health risk assessment.No further review required.Conclusion: the evaluation verified the complaint as valid; the cause of the complaint issue was identified as a defective sensor board.

• Brand Name: INTER-CRANIAL PRESSURE AND TEMPERATURE MONITOR
• Type of Device: ICP MONITORING
• Manufacturer (Section D): INTEGRA LIFESCIENCES(IRELAND); ida business&technology park; ida business&technology park; sragh, tullamore, co.offaly ; EI
• Manufacturer (Section G): INTEGRA LIFESCIENCES(IRELAND); ida business&technology park; sragh, tullamore, co.offaly ; EI
• Manufacturer Contact: rowena bunuan ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 6352386
• MDR Text Key: 68511966
• Report Number: 3006697299-2017-00033
• Device Sequence Number: 1
• Product Code: GWM
• Combination Product (y/n): N
• PMA/PMN Number: K121573
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/03/2017

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
• Device Operator: Health Professional
• Device Catalogue Number: CAM02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/03/2017
• Initial Date FDA Received: 02/23/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1