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

Catalog Number CAM02

Device Problems Signal Artifact/Noise (1036); Improper Device Output (2953)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

During incoming inspection of the device by the distributor, some abnormal signs (interferences) were noticed on the display when connecting or moving of the camino cable (camcabl).There was no patient involvement.Linked to mfg.Report numbers: 3006697299-2017-00039, 3006697299-2017-00040, 3006697299-2017-00042, 3006697299-2017-00041.

Manufacturer Narrative

Investigation completed 5/29/17.Method: device history review.Trend analysis.Failure analysis.The dhr review was completed for cam02 monitor serial number (b)(4).The dhr review verified no anomalies that could be associated with the complaint were observed.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.Date of manufacture: 2015 ¿ sep.An review of cam02 monitor customer complaints was competed using the following key words ¿display¿ and ¿abnormal signs/interferences on display when connecting /moving camcabl¿ in the search criteria.The review encompassed dates 10-feb-16 to 16 -feb -17.There were 2 complaints contained in the search criteria.Additionally, the review verified pr this complaint is the single complaint occurrence for serial number 1150902850 rate of occurrence: during the time period ¿feb 16 to feb 17¿, the global product usage for cam02 monitors was calculated as 26,437 usages, using the total quantity of cam02 monitor catheter sales sold to calculate the quantity of usages.1 catheter is used per procedure, and is used as a means of quantifying the number of procedures undertaken.The quantity of complaints in the complaint review (2) can therefore be calculated as 0.008% (8 x 10-5) (occasional) of procedures.The product was returned to the manufacturing facility for failure analysis evaluation which was unable to conclusively verify the complaint as valid.The cam02 monitor was verified as performing to specification and was confirmed as not the cause of the complaint incident.The camcabl serial number (b)(4) which was shipped with the cam02 monitor to the customer was verified as the cause of the complaint incident.The cable failure is evaluated through mfg.Report number: 3006697299-2017-00040.The cam02 monitor was verified as performing to specification and is not the cause of the complaint incident.Future incidents of this nature will be documented for recurrence and trending purpose.Conclusion: the evaluation was unable to conclusively verify the complaint as valid.Therefore, an investigation for cause was unable to be performed.The cam02 monitor was verified as performing to specification.

• 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: rowena bunuan ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 6365844
• MDR Text Key: 69015594
• Report Number: 3006697299-2017-00038
• 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: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: CAM02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/29/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2015
• 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