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

Catalog Number PAC2

Device Problems Electromagnetic Interference (1194); Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

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 information.

Event Description

This is the eleventh of twelve reports (same reporter, same problem, same product id, different serial numbers).After the cable was connected to the monitor, it showed interference in the screen graphic.All of the cables had this problem.The cables were new and never used.After technical evaluation, the connectors that receive the catheter were not connected to ground."they received interference, amplify and generate problem." the problem was discovered by the distributor.No patient involved.

• Brand Name: PRE-AMP CABLE, SPM-1 CONNECTS MONITOR TO CATHETER
• Type of Device: NA
• Manufacturer (Section D): INTEGRA NEUROSCIENCES, LTD.; andover hampshire SP10 4DR; UK SP104DR
• Manufacturer Contact: rowena bunuan ; 315 enterprise dr.; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 4307486
• MDR Text Key: 19370540
• Report Number: 8010219-2014-00070
• Device Sequence Number: 1
• Product Code: GWM
• Combination Product (y/n): N
• PMA/PMN Number: K031086
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: PAC2
• Device Lot Number: 534220
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/12/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1