MAUDE Adverse Event Report: INTEGRA LIFESCIENCES(IRELAND) CAMINO ADVANCED MONITOR WITH ICP WAVEFORM, ICT,; N/A

Catalog Number CAM01

Device Problems Failure to Select Signal (1582); Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913); Device-Device Incompatibility (2919)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 05/15/2017

Event Type  malfunction  

Event Description

It was reported that the cam01 monitor is not recognizing known good catheters.It was unknown if there was patient contact, or surgical delay.There was no patient injury/death alleged, and no revision/medical intervention required.Additional information request was sent and on 19 may2017, the following was provided by the customer.The clinical leader and attending doctor was performing a procedure on (b)(6) 2017, for educational purposes.It was reported that the screen would not switch to the monitor mode once a catheter was plugged in.The error message displayed was integra logo splash screen.At least four different catheters (all were used for educational purposes, including a new catheter), and the screen would never change from the integra science logo.The complaint reported they were unable to get to the screen for the catheter to be zeroed to atmosphere by using zeroing tool provided prior to implantation.No patient involvement, therefore, no patient was moved, nor catheter or cable clip was being used.No patient harm or injury.The catheters were swapped with known good/new ones.Two catheters were used on other unit and was successful( lot no.197015-l-14).

Manufacturer Narrative

Investigation completed 6/26/2017.The dhr documentation was reviewed and no anomalies that could be associated with the complaint incident were observed.Date of manufacture: jan-2010.Service history: service history reviewed and no anomalies that could be associated with the complaint incident were observed.A minimum of 12 months¿ review of cam01 monitor customer complaints was using the following key words ¿faulty preamp flex cable ¿ internal cable¿ in the search criteria.This review encompassed dates 23-june-2016 to 26-june-2017.A total of 2 complaints were reviewed of which this complaint incident is the 1st complaint for the cam01 monitor with the root cause identified as a faulty preamp flex cable.In addition to trending, the customer complaints review identified no other complaints being received in this period for serial number under investigation.During investigation it was observed that the cam01 monitor did not pass the logo screen and did not recognize the catheter due to faulty preamp flex cable.The defective cable is an internal cable that is not serialized.As part of the repair, the following parts were replaced: internal preamp flex cable ((b)(4)) and dfu.The monitor was calibrated and tested to specification prior to being returned to customer.Product was returned and the evaluation verified the complaint incident as valid.Root cause determined; faulty internal preamp flex cable.

• Brand Name: CAMINO ADVANCED MONITOR WITH ICP WAVEFORM, ICT,
• Type of Device: N/A
• 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: 6587514
• MDR Text Key: 76039496
• Report Number: 3006697299-2017-00085
• Device Sequence Number: 1
• Product Code: GWM
• Combination Product (y/n): N
• PMA/PMN Number: K962928
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CAM01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2010
• 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