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); Connection Problem (2900); 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 twelfth 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 was found upon inspection of the unit after the initial receipt of product from the manufacturer.It was not 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

Internal investigation was completed on 09/01/2015: methods: evaluation of actual device.Device history review.Complaint history review.Results: 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.Customer complaint was not confirmed.Dhr review was completed for pac2 cable serial number (b)(4), to identify any recorded anomalies that could be associated to the complaint incident.Date of manufacture: sep-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.The complaint incident was initiated for monitor cable pac2 therefore there is no service history to be reviewed.The dhr review has been deemed satisfactory.(b)(4).Conclusion: since the complaint incident could not be duplicated and the cable was verified as working within specifications no root cause can be established.

• 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: linda serentino ; 315 enterprise drive; 6099365560
• MDR Report Key: 4736593
• MDR Text Key: 5884472
• Report Number: 8010219-2015-00020
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PAC2
• Device Lot Number: 543680
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/30/2015
• Initial Date FDA Received: 04/27/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2014
• 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