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

Catalog Number CAM02

Device Problem Device Sensing Problem (2917)

Patient Problem No Patient Involvement (2645)

Event Date 12/03/2014

Event Type  malfunction  

Event Description

This is the second of three reports (same incident, same product problem, same product ids, different serial numbers).The cam02 not was not sensing any touch screens.There was never a pt involved on any of the equipment.The nurse went to go get one to use and they found three of them that did not have a response to the touch screen.There were spare products available to be used.There was no surgery delay.

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.

• 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: rowen bunuan ; 315 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 4380093
• MDR Text Key: 18730213
• Report Number: 3006697299-2014-00148
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/24/2014
• 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?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/03/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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