MAUDE Adverse Event Report: INTEGRA NEUROSCIENCES, LTD. PRE-AMP CABLE, SPM-1 CONNECTS MONITOR TO CATHETE

Catalog Number PAC2

Device Problems Signal Artifact/Noise (1036); Electromagnetic Interference (1194); Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 03/24/2015

Event Type  malfunction  

Event Description

This is the fourth of twelve reports (same reporter, same product id, same product problem, different serial numbers).It was reported that the receptacle that engages the catheter was not connected to the ground and when they touch the finger, they realized that the monitor showed an interference at the mpm-1 and showed an error in the spm-1.For other cables that worked, the receptacle was connected to ground and didn't have a problem.A multimeter was used to check this problem.The cable has never been used.The product problem was found upon inspection of the unit after the initial receipt of product from the manufacturer.It was found during set up for a procedure.There was no patient involvement.There was no procedure delay.

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 information.

Manufacturer Narrative

Integra completed its internal investigation 8/26/2015.The investigation included: method: dhr review, complaint trend, visual inspection.Results: dhr review was completed for pac2 cable serial number (b)(4).Date of manufacture: nov-2014.No non-conformance reports were raised during the manufacturing process for this cable.All results of the functionality tests were recorded as within specification and final release checks were performed satisfactory prior to the cable been released.Based on previous customer complaints, it can be concluded that the complaint incident is a failure of the cable to interact with the icp monitor.Since there is no reference to an interaction of the cable with the catheter, the reported failure is trended as cable to monitor interaction failure, therefore a minimum of 12 month review of pac2 cable customer complaints was completed using the following key words ¿cable to monitor connection failure¿ and a root cause ¿could not duplicate¿ in the search criteria.(b)(4).Reported failure was not confirmed; engineering investigation could not duplicate the interference at mpm-1 monitor and was not able to evaluate an error in spm-1 monitor as no fully functional, calibrated monitor was available.Further investigation completed by service centre could not duplicate an error in spm-1 monitor.Pac2 cable was verified as working within specifications; no fault was found.Conclusion: the reported failure ¿pac2 pre-amp cable, monitor show an interference at mpm-1 and show error in spm-1¿ was not verified and could not be duplicated, therefore, no root cause can be determined.

• Brand Name: PRE-AMP CABLE, SPM-1 CONNECTS MONITOR TO CATHETE
• 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; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 4730084
• MDR Text Key: 16633224
• Report Number: 8010219-2015-00012
• Device Sequence Number: 1
• Product Code: GWM
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K031086
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor,distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2015
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: PAC2
• Device Lot Number: 544440
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/26/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2014
• 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