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

Catalog Number PAC1

Device Problems No Display/Image (1183); Connection Problem (2900); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/14/2014

Event Type  malfunction  

Event Description

During a trouble-shooting exercise in the user facility, integra senior product support engineer used a mpm (multiparameter monitor) and pac1 that had just been received from integra service following repair.The pac1 was noted to have a connection issue with intermittent screen display versus check connection message.The product was not in contact with a patient, there was no patient injury or death alleged, and there was no significant increase in surgery time.Additional information was received on (b)(6) 2014 that the cable was tested by the (b)(6) hospital medical engineers and it did not pass their quality tests for the following reasons: during testing, the reading jumped to 300 mmhg at random and the casing split on the block connector.

Manufacturer Narrative

It is unknown if the device involved in the reported incident is expected to be returned for evaluation.An investigation has been initiated based upon the reported information.

• Brand Name: PRE-AMP CABLE, MPM-1 CONNECTS MONITOR TO CATHET
• Type of Device: NA
• Manufacturer (Section D): INTEGRA NEUROSCIENCES, LTD.; andover hampshire SP10 4DR; UK SP104DR
• Manufacturer Contact: rowena bunuan ; 315 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 4105606
• MDR Text Key: 4713134
• Report Number: 8010219-2014-00046
• Device Sequence Number: 1
• Product Code: GWM
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K962928
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/14/2014

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: PAC1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/21/2014
• Initial Date FDA Received: 09/09/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: (B)(4)