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

Catalog Number CAM02

Device Problems Loose or Intermittent Connection (1371); Mechanical Problem (1384); Product Quality Problem (1506); Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 01/17/2017

Event Type  malfunction  

Event Description

Customer said they opened the box and took device out and it sounded as if screws were inside the box rolling around.There was no patient involvement.

Manufacturer Narrative

Integra has completed their internal investigation on april 7, 2017.Results: product was not returned so the evaluation was unable to be performed.Dhr review; the serial number of the cam02 monitor was not provided for this complaint incident.The cam02 monitor serial number is required to complete a dhr review.The dhr review will be completed during the failure analysis investigation if the serial number becomes available.Complaints history; the review encompassed dates 20-jan-16 to 09-feb -17.A total of 151 complaints were reviewed of which there are 3 complaints which contained the search criteria.During the time period ¿jan 16 to feb 17¿, the global product usage for cam02 monitors combined was calculated as (b)(4) 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 (3) can therefore be calculated as (b)(4).Conclusion: product was not returned, therefore, an investigation for cause was unable to be performed.If the product is returned for evaluation the complaint will be reopened and the evaluation will be completed.

Manufacturer Narrative

Investigation completed 10/05/2017.The serial number of the device was confirmed as (b)(4) during the failure evaluation when the product was received.The dhr was reviewed and no anomalies that could be associated with the complaint incident were observed.Date of manufacture: 2016 ¿ sep.Complaint trend review performed per the reported failure and verified as required to be updated.The complaint was verified as valid; the cause was verified as a missing screw from the single board computer due to manufacturing error.Dissemination of the complaint incident was completed through awareness training.

• 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: 6332395
• MDR Text Key: 67846669
• Report Number: 3006697299-2017-00029
• 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: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2017
• 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: 02/08/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2017
• 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