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

Catalog Number CAM02

Device Problems Break (1069); Out-Of-Box Failure (2311); Noise, Audible (3273)

Patient Problem No Patient Involvement (2645)

Event Date 06/06/2016

Event Type  malfunction  

Event Description

A report was received for the cam02 inter-cranial pressure and temperature monitor that something was rattling around the inside of the unit.It was not certain if it was hardware, a nut, or something else.The problem was noticed on (b)(6) 2016, upon inspection of the device, and there was no patient involvement.It was considered an out of box failure.

Manufacturer Narrative

Integra has completed their internal investigation on 21jul2016.The investigation included: methods: evaluation of actual device, review of device history records, review of complaint history.Results: evaluation of device: the failure analysis investigation verified the complaint incident; a piece of cut zip tie was inside the unit which resulting the rattling noise as reported.Trackwise was populated with a summary of the complaint investigation.The piece of zip tie was removed and the monitor was calibrated and safety tested as per as per f0421camino 2 monitor service record.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.The dhr pack was reviewed for cam02 monitor serial number (b)(4), date of manufacture: jul - 2014; no non-conformance reports were raised during the manufacturing process for this monitor.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.Based on the service report supplied, a review of cam02 complaints was completed in trackwise using the following key words ¿touchscreen¿ and a root cause ¿loose cable¿ in the search criteria.The review encompassed dates (b)(6) 2014 to (b)(4) 2015.A total of (b)(4) complaints were reviewed of which this complaint is the only instance of the complaint incident.Based on the above complaint review a trend is not identified.Future incidents of this nature will be documented for recurrence and trending purposes.Rate of occurrence: during the time period ¿(b)(6) 2014 to (b)(6) 2015¿, the global product usage for cam02 monitors was calculated as (b)(4) usages, using the total quantity of cam02 monitor catheter sales sold per cam02 monitor customer to calculate the quantity of usages.(b)(4) catheter is used per procedure, and is used as a means of quantifying the number of procedures undertaken.The quantity of complaints ((b)(4)) over the review period with the key word identified in the complaint review can therefore be calculated as (b)(4)% (4 x 10-5) of procedures.This percentage is below the ¿occasional¿ rate of occurrence scored in the health risk assessment against (b)(4) cam02 and licox risk management plan.Future complaints will be continued to be monitored and trended.Conclusion: a root cause could not be established.One previous service activity was completed; the replacement of a sensor board.The cause of this complaint incident is possibly as a result of the service activities performed however a definitive root cause cannot be established.

• Brand Name: INTER-CRANIAL PRESSURE AND TEMPERATURE MONITOR
• Type of Device: ICP MONITORING
• Manufacturer (Section D): INTEGRA LIFESCIENCES(IRELAND); ida business&technology park; ida business&technology park; sragh, tullamore, co.offaly ; EI
• Manufacturer (Section G): INTEGRA LIFESCIENCES(IRELAND); ida business&technology park; sragh, tullamore, co.offaly ; EI
• Manufacturer Contact: bina patel ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 5743490
• MDR Text Key: 48834581
• Report Number: 3006697299-2016-00149
• 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: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2016
• 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: 06/22/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/21/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2014
• 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