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); Image Display Error/Artifact (1304)

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

Event Type  malfunction  

Event Description

The camino monitor was reported to have an issue with the screen.No other info was provided.Add'l info has been requested.

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.

Manufacturer Narrative

Integra has completed their internal investigation on 07/27/2015.The investigation included: evaluation of actual device , review of device history records, review of complaints history.Results: the customer complaint incident was confirmed and duplicated.The root cause of the issue with the screen was verified as a defective touchscreen flex cable.The dhr pack appendix 1 was reviewed for cam02 monitor serial number (b)(4).Date of manufacture: 2013-may.This review verified there are no assignable cause and/or anomalies associated at manufacturing process of the cam02 monitor production process which could contribute and/or be related to the reported incident.Service history: during the time period ¿jan 14 to jan 15¿, the global product usage for cam02 and lcx02 monitors was calculated as (b)(4) usages, using the total quantity of cam02 and lcx02 monitor catheter sales sold to calculate the quantity of usages.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.Conclusion: the root cause of the issue with the screen was verified as a defective touchscreen flex cable.

• 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 (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: 4524282
• MDR Text Key: 5495191
• Report Number: 3006697299-2015-00018
• Device Sequence Number: 1
• Product Code: GWM
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K121573
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2015
• 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: 01/22/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/27/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2013
• 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