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

Catalog Number CAM02

Device Problems Image Display Error/Artifact (1304); Failure to Power Up (1476); Out-Of-Box Failure (2311); Charging Problem (2892)

Patient Problems No Consequences Or Impact To Patient (2199); No Information (3190)

Event Date 04/02/2015

Event Type  malfunction  

Event Description

It was reported that a cam02 touchscreen was not working properly.The description was provided by the educator who was present during this event.When the monitor was turned on it powered up as usual; however, the touch screen was not working properly.It would work some times and then not other times."i turned off the monitor at least 6 times.It had a partially charged battery".This was the first time it had ever been used.The touch screen did start to improve but never worked accurately to my satisfaction.The scale button would not activate the change in scale.When you were finished with the sync button and hit the done button, it would take you immediately to the settings screen.I attached a brand new catheter to the monitor to do further testing.The catheter and it did allow me to zero the catheter with the adjustment screw and zero appeared in the icp screen.The physician did use this monitor to zero the catheter prior to insertion into the pt.Once the catheter was placed the pt was sent to post op recovery.

Manufacturer Narrative

The device involved in the reported incident has been received for eval.An investigation has been installed based upon the reported info.

Manufacturer Narrative

Integra has completed their internal investigation on 10/27/2015.The investigation included: methods: evaluation of actual device.Review of device history records.Review of complaints history.Results: the customer complaint incident was confirmed and duplicated.The failure analysis investigation verified the touchscreen failure was due to a partially collapsed air gap, resulting in an intermittent contact between the touch surfaces.The dhr pack was reviewed for cam02 monitor serial number (b)(4).Date of manufacture: 2012 ¿ oct.Two non-conformance reports were raised during the manufacturing process for this console.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.Service history: there is no service history for cam02 monitor (b)(4).Rate of occurrence: during the time period ¿apr 2014 to apr 2015¿, the quantity of complaints over the review period with the key word identified in the complaint review can therefore be calculated as (b)(4).Conclusion: the root cause of the touch screen failure was due to a partially collapsed air gap, resulting in an intermittent contact between the touch surfaces.

• 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: linda serentino ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 4733272
• MDR Text Key: 5582692
• Report Number: 3006697299-2015-00057
• 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: Company Representative,company representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 04/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2015
• 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: 08/10/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/27/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2012
• 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
• Patient Age: 17 YR