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

Catalog Number CAM02

Device Problems Display or Visual Feedback Problem (1184); Improper Device Output (2953)

Patient Problem No Patient Involvement (2645)

Event Date 06/25/2015

Event Type  malfunction  

Manufacturer Narrative

To date, the device involved in the reported incident has not been received for eval.An investigation has been initiated based upon the reported info.

Event Description

It was reported that the display was not working properly.There was no pt contact, there was no pt prepped for surgery, no pt injury, and no delay in surgery.Additional info was received from the customer on 07/10/2015: on (b)(6) 2015, the device was turned on during inspection to verify operation after it was returned from service.It was confirmed that the problem did not involve a pt nor was it during surgery.

Manufacturer Narrative

Integra has completed their internal investigation on 08/25/2015.The investigation included: evaluation of actual device, review of device history review, review of complaints history.Results: based on the complaint evaluation verifying the touchscreen was defective and in conjunction with the complaint review verifying the complaint incident is a single occurrence, no corrective actions are deemed necessary for cam02 monitors.Future incidents of this nature will be documented for recurrence and trending purposes.The dhr was reviewed for cam02 monitor serial number (b)(4).Date of manufacture: 2014 ¿ may.No non-conformance reports were raised during the manufacturing process for this console.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: a review of similar complaints during the time period ¿jun 14 to jul 15¿, the quantity of complaints over the review period with the key word identified in the complaint review (3) can therefore be calculated as 0.02 (2 x 10 ¯4) of procedures.This percentage is above the ¿remote¿ rate of occurrence scored in the cam02 monitor¿s pfmea issue 2 risk management reviews.Conclusion: the failure analysis investigation identified a defective touchscreen was the root cause of the complaint incident ¿display not working properly¿.

• Brand Name: INTER-CRANIAL PRESSURE AND TEMPERATURE MONITOR
• Type of Device: ICP MONITORING
• Manufacturer (Section D): INTEGRA LIFESCIENCES IRELAND LIMITED; sragh tullamore ; EI
• Manufacturer (Section G): INTEGRA LIFESCIENCES(IRELAND); ida business&technology park; sragh, tullamore, co.offaly ; EI
• Manufacturer Contact: rowena bunuan ; 315 enterprise dr.; plainsboro , NJ 08536 ; 6099362393
• MDR Report Key: 4931010
• MDR Text Key: 22528359
• Report Number: 3006697299-2015-00105
• Device Sequence Number: 1
• Product Code: GWM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121573
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Report Date: 06/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2015
• 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: 06/30/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/25/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2014
• 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