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

Catalog Number CAM02

Device Problems No Device Output (1435); Failure to Power Up (1476)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

It was reported that the device would not boot up.Additional information has been requested.

Manufacturer Narrative

Integra has completed their internal investigation on 11/10/2015.The investigation included: methods: evaluation of actual device, review of device history records, review of complaints history.Results: the customer complaint incident was duplicated and confirmed.Dhr was reviewed for cam02 monitor serial number (b)(4).Date of manufacture: 2014 ¿ jun.No non-conformance report was raised during the manufacturing process for this monitor.The dhr review verified 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.Rate of occurrence: (b)(4).The cam02 user guide was reviewed to ensure adequate instructions are provided to the user indicating the cam02 monitor cannot be immersed in water, no fluids directly on the monitor.Chapter 3; setting up system for clinical use.Adequate instructions are provided to advise the user per appropriate storage of the monitor and mounting of the monitor during use.Clear instructions are provided to advise the user the monitor to ensure fluid/liquid ingress is not advised.Chapter 7; cleaning and sterilizing the system.Clear instructions are provided to the user indicating the monitor cannot be immersed in fluid or have fluid directly sprayed on the housing.Conclusion: the root cause evaluation identified fluid damage on the sensor board, power board and embedded board which resulted in the monitor failing to boot up as reported.

• 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: 5193010
• MDR Text Key: 30356467
• Report Number: 3006697299-2015-00158
• 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: 10/12/2015

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: 10/21/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/29/2015
• Initial Date FDA Received: 10/30/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/08/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2014
• 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