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

Catalog Number CAM02

Device Problems Device Operates Differently Than Expected (2913); Data Problem (3196)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 06/12/2017

Event Type  malfunction  

Event Description

The unit was not reporting correct data even when the disposable has been changed out.Additional information has been requested.Linked to mfg.Report number: 3006697299-2017-00107.

Manufacturer Narrative

Investigation completed 08/28/2017.The dhr was reviewed and no anomalies that could be associated with the complaint incident were observed.Date of manufacture: 2015 ¿ feb.A review of the customer complaints was completed using the following key words ¿unit is not reporting correct data¿ and ¿results or readings¿ in the search criteria.The review encompassed dates 18-jul-16 to 18-jul -17.There are 2 complaints which contained the search criteria.The complaints are linked; this complaint evaluation is the 2nd complaint incident reported by the facility for the device under evaluation and the 2nd instance of the failure mode.Rate of occurrence: during the time period ¿aug 16 to jul 17¿, the global product usage for cam02 monitors was calculated as 22,134 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 0.010%.The evaluation was unable to conclusively verify the complaint as valid.Therefore, an investigation for cause was unable to be performed.

• 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: 6704292
• MDR Text Key: 79933726
• Report Number: 3006697299-2017-00108
• 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: Dental Hygienist
• Type of Report: Initial,Followup
• Report Date: 06/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2017
• 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: 08/11/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2015
• 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