MAUDE Adverse Event Report: INTEGRA LIFESCIENCES (IRELAND) LTD. PRE-AMP CABLE, MPM-1. CONNECTS MONITOR TO CATHET; N/A

Catalog Number PAC1

Device Problems Communication or Transmission Problem (2896); Data Problem (3196)

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

Event Date 03/21/2016

Event Type  malfunction  

Event Description

It was reported that there was no data transfer when an icp catheter was connected.The screen did not change even when the icp catheter was connected.It was confirmed that mpm monitor was working via cross check.Additional information has been requested.

Manufacturer Narrative

Additional information received from the distributor on 09may2016: the date of incident was on (b)(6) 2016.The issue occurred during surgery.No patient identifiers were provided.There was no patient injury reported and no surgery delay.A replacement cable was available to be used.

Manufacturer Narrative

Integra has completed their internal investigation on 16may2016.The investigation included: methods: -evaluation of actual device -review of device history records.-review of complaint history.Results: evaluation of device: during investigation the pac-1 cable was tested within specification when tested with test monitor; no fault was found.No non-conformance reports were raised during the manufacturing process for this cable.The dhr review has been deemed satisfactory.A minimum of 12 month review of pac-1 monitor customer complaints was completed in using the following key words ¿pressure display issue¿ and a root cause ¿could not duplicate¿ in search criteria.This review encompassed from dates 28-mar-2015 to 09-may-2016.A total of 7 complaints were reviewed of which 3 complaints contained the search criteria.The analysis of the complaint investigations and root cause reports has concluded this complaint is the 1st identified complaint for the reported failure associated with pac-1 cable that could not be duplicated.No trend has been identified.Conclusion: since the complaint incident could not be duplicated and the pac-1 cable was verified as working to specifications, no root cause can be established.

• Brand Name: PRE-AMP CABLE, MPM-1. CONNECTS MONITOR TO CATHET
• Type of Device: N/A
• Manufacturer (Section D): INTEGRA LIFESCIENCES (IRELAND) LTD.; sragh tullamore, co. offaly ; EI
• Manufacturer (Section G): INTEGRA LIFESCIENCES (IRELAND) LTD.; sragh tullamore, co. offaly ; EI
• Manufacturer Contact: rowena bunuan ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 5586679
• MDR Text Key: 43996719
• Report Number: 3006697299-2016-00113
• Device Sequence Number: 1
• Product Code: GWM
• Combination Product (y/n): N
• PMA/PMN Number: K962928
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: PAC1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/16/2016
• 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