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

Catalog Number CAM02

Device Problems Mechanical Problem (1384); Device Inoperable (1663); Out-Of-Box Failure (2311)

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

Event Type  malfunction  

Event Description

It was reported that the touch screen display of a cam02 did not function.It was impossible to perform any basic settings or navigate to the menu options.The technician experienced this issue the first time when they opened the box (sealed box).

Manufacturer Narrative

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

Manufacturer Narrative

Integra completed its internal investigation 07/16/2015.The investigation included: method, service history, review of complaint management database for similar complaints, visual.Results: the dhr pack was reviewed for cam02 monitor serial number (b)(4).Date of manufacture: july 2013 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.Service history: there is no other service history for review - a review of cam02 complaints was completed using the following key word "touchscreen" in the search criteria.The review encompassed dates (b)(6) 2013 to (b)(6) 2014.The review identified (b)(4) complaints were reported for touchscreen failure with (b)(4) complaints root cause identified as an air gap in the touchscreen assembly which resulted in the failure of the touchscreen.Capa was initiated as a result of the complaint trending.Rate of occurrence: the quantity of complaints over the 12 month period with the key word identified in the complaint review can therefore be calculated as (b)(4) % of procedures.The failure analysis investigation verified the complaint incident.The power board was confirmed as defective and the power cable from the touch control pcb required to be corrected.The cam02 monitor received a replacement power board, was calibrated and safety tested.The results were reviewed as part of this investigation, all the functionality tests were carried out accordingly and all results of the tests were recorded as within specification.Conclusion: the failure analysis investigation has concluded the root cause of the touch screen failure was due to a defective power board.

• Brand Name: INTER-CRANIAL PRESSURE AND TEMPERATURE MONITOR
• Type of Device: ICP MONITORING
• Manufacturer (Section D): INTEGRA LIFESCIENCES (IRELAND) LIMITED; sragh, tullamore, co.; offaly ; EI
• Manufacturer Contact: linda serentino ; 315 enterprise drive; 6099365560
• MDR Report Key: 4535405
• MDR Text Key: 5353477
• Report Number: 3006697299-2015-00016
• 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: Foreign,Distributor,distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: CAM02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/19/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1