MAUDE Adverse Event Report: INTEGRA NEUROSCIENCES, LTD. CAMINO ADVANCED MONITOR WITH ICP WAVEFORM, ICT,

Catalog Number CAM01

Device Problems No Display/Image (1183); Display or Visual Feedback Problem (1184)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

To date, the device involved in the reported incident has not been received for evaluation.An investigation has been initiated based upon the reported info.

Event Description

It was reported that the monitor was put into use for a couple weeks.Without cause, the monitor would not move past the integra logo screen.The user tested it several times with cables/catheters (required to move past logo screen) to no avail.There was no pt injury.Additional info was received from the customer on (b)(6) 2015: this problem was identified during a surgical case.They tried to use the device but couldn't get past the logo screen.They immediately pulled it from the service and used a different unit with no issues.

Manufacturer Narrative

Integra has completed their internal investigation on 11/16/2015.The investigation included: methods: evaluation of actual device.Review of device history records.Review of complaints history.Results: the reported failure ¿monitor will not move past the integra logo screen¿ was verified and duplicated.Customer complaint was confirmed.Dhr review was completed for cam01 monitor serial number (b)(4), to identify any recorded anomalies that could be associated to the complaint incident.Date of manufacture: sep-2012, no non-conformance reports were raised during manufacturing process for this monitor.A minimum of 12 month review of cam01 monitor customer complaints was completed in trackwise® using the following key words ¿display issue¿ and a root cause ¿analog pcb¿ in the search criteria.The analysis of the complaint investigations and root cause reports has concluded this is the 1st identified complaint for the reported failure associated with the cam01 monitor due to faulty analog board.No trend has been identified.Trending analysis has concluded no further action is required for the complaint investigation.No review of non-conformance reports (ncrs) is deemed necessary as no trend has been identified.No further actions are deemed necessary.Future complaints will be continued to be monitored and trended.Conclusion: the failure analysis investigation has concluded the root cause of the cam01 monitor not moving past integra logo screen was due to faulty analog board assembly of the cam01 monitor.

• Brand Name: CAMINO ADVANCED MONITOR WITH ICP WAVEFORM, ICT,
• Type of Device: NA
• Manufacturer (Section D): INTEGRA NEUROSCIENCES, LTD.; andover hampshire SP104 DR; UK SP104DR
• Manufacturer (Section G): INTEGRA NEUROSCIENCES, LTD; newbury road; andover hampshire ; UK
• Manufacturer Contact: rowena bunuan ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 4942176
• MDR Text Key: 22850510
• Report Number: 8010219-2015-00034
• Device Sequence Number: 1
• Product Code: GWM
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: Followup
• Report Date: 06/29/2015

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: Health Professional
• Device Catalogue Number: CAM01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/23/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/10/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2012
• 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