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

Catalog Number CAM02

Device Problems Signal Artifact/Noise (1036); No Display/Image (1183); Connection Problem (2900)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

It was reported that during the preliminary inspection of the product by the distributor, some abnormal signs (interferences) were found on the monitor¿s display when connecting or moving the cable (camcabl).This unit has not been sent to any customer.No patient was involved.There was no patient injury or medical intervention required.Linked to mfg report # 3006697299-2017-00070.

Manufacturer Narrative

Investigation completed 5/30/17.Method: device history review: trend analysis.The dhr was reviewed and no anomalies that could be associated with the complaint incident were observed.Date of manufacture: 2016 - sep.A 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 05-jun-16 to 05-may -17.There are 3 complaints which contained the search criteria.Additionally, the review verified that this complaint is the single complaint occurrence for the serial number under investigation for this complaint.Rate of occurrence: during the time period ¿jun 16 to may 17¿, the global product usage for cam02 monitors 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) (occasional) of procedures.Conclusion: product was not returned for evaluation after several documented attempts.Therefore, we are unable to determine root cause at this time.

• 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: annette orlando ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 6557899
• MDR Text Key: 74912501
• Report Number: 3006697299-2017-00071
• 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: 04/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/27/2017
• Initial Date FDA Received: 05/10/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/26/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2016
• 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